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9,521 catalysts · 3,350 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 584 earnings

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 66 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • 8k filing3,350
  • grant2,032
  • device adverse event1,000
  • approval910
  • device 510k674
  • earnings584
device pma
508
  • device recall215
  • phase 2 completion172
  • recall167
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 23, 2026

    50
    ›Feb 27, 2026device pma169d agoTeleflex Medical, LLC — MANTA™ Vascular Closure Device (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoIntegra LifeSciences Corporation — DuraSeal Dural Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

    Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoRoche Diagnostics Corp. — Elecsys total PSA assay (PMA supplement)CS DIAGNOSTICS CORP.

    Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoRoche Diagnostics Corp. — Elecsys free PSA assay (PMA supplement)CS DIAGNOSTICS CORP.

    Supplement type: 30-Day Notice. Product code: LTJ. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoABBOTT MEDICAL — Next Gen Patient System – CM1200 CardioMEMS HERO Device (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MOM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic Vascular — Endurant™, Endurant™ II/lls Stent Graft System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic Vascular — Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoSymatese — Evolysse™ Smooth; Evolysse™ Form (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device recall169d agoGE Healthcare LLC device recall (Cls II)

    SIGNA Premier systems — Reason: Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoOlympus Corporation of the Americas device recall (Cls II)

    Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No — Reason: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107 — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596 — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472 — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoOlympus Corporation of the Americas device recall (Cls II)

    Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No — Reason: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107 — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIOB686; 9. RADIO ANGIO UNIV HOSP PACK-LF, Medline SKU # DYNJ0376145M; 10. SPECIALS PACK-LF, Medline SKU # DYNJ0392706K; 11. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426O; 12. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426P; 13. CARDIAC CATH PACK, Medline SKU # DYNJ07953N; 14. CATH PACK-LF, Medline SKU # DYNJ0803367J; 15. E.P. TRAY, Medline SKU # DYNJ19343J; 16. CARDIAC CATH PACK, Medline SKU # DYNJ20898T; 17. CATH LAB TRAY, Medline SKU # DYNJ24250G; 18. CATH LAB PACK-LF, Medline SKU # DYNJ38333D; 19. CATH LAB PACK-LF, Medline SKU # DYNJ38333F; 20. EP IMPLANT PACK-LF, Medline SKU # DYNJ38910D; 21. ADULT CATH LAB PACK, Medline SKU # DYNJ40380J; 22. CRANIOTOMY PACK-LF, Medline SKU # DYNJ43403D; 23. LAP CHOLE PACK, Medline SKU # DYNJ48487F; 24. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779G; 25. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779I; 26. HYBRID, Medline SKU # DYNJ57049N; 27. SPECIALS PK, Medline SKU # DYNJ57713C; 28. SPECIALS PK, Medline SKU # DYNJ57713D; 29. SPECIALS PK, Medline SKU # DYNJ57713F; 30. CARDIAC CATH LAB, Medline SKU # DYNJ57748A; 31. TAVR PACK, Medline SKU # DYNJ58771G; 32. CATH PACK GWV, Medline SKU # DYNJ59229F; 33. HEART CATH PACK, Medline SKU # DYNJ61294F; 34. CATH LAB PACK, Medline SKU # DYNJ61353C; 35. DEVICE IMPLANT PACK, Medline SKU # DYNJ64636A; 36. CUSTOM PROCEDURE KIT, Medline SKU # DYNJ65277A; 37. GENERAL VASCULAR PACK RFID-V2, Medline SKU # DYNJ66442F; 38. CARDIAC CATH PACK, Medline SKU # DYNJ69845C; 39. OMF MINOR PACK, Medline SKU # DYNJ83991C; 40. HEART CATH PACK, Medline SKU # DYNJ84133B; 41. SPECIAL PROCEDURES, Medline SKU # DYNJ85425B; 42. PRIMARY PACK, Medline SKU # DYNJT3093; 43. CARDIAC CATH PACK, Medline SKU # DYNJT3522A; 44. CARDIAC CATH PACK, Medline SKU # DYNJT3522B; 45. TOTAL KNEE PACK, Medline SKU # DYNJT4069; 46. CARDIAC CATH PACK, Medline SKU # DYNJT5685; 47. CATH PACK, Medline SKU # DYNJT6544; 48. PACK CARDIAC CATH, Medline SKU # DYNJT7591; 49. OBL CATH VEIN PACK, Medline SKU # DYNJT7863; 50. TUMESCENT SYRINGE KIT, Medline SKU # DYNJTUMSYR; 51. CSTM LH KIT, Medline SKU # VASC1054; 52. LHK, Medline SKU # VASC1130A; 53. MANIFOLD KIT, Medline SKU # VASC1137A; 54. LHK, Medline SKU # VASC1299A; 55. LHK, Medline SKU # VASC1399B; 56. LHK, Medline SKU # VASC1403; 57. IR 2 PORT, Medline SKU # VASC1404; 58. LHK, Medline SKU # VASC1405; 59. LHK, Medline SKU # VASC1455A; 60. TWO PORT MANIFOLD KIT, Medline SKU # VASC1496; 61. RHK, US, NAMIC MANIFOLD, Medline SKU # VASC1502; 62. LHK, Medline SKU # VASC1555; 63. 4 VALVE,PERC,MANIFOLD,KIT, Medline SKU # VASC1609; 64. LHK, Medline SKU # VASC1668; 65. LHK, Medline SKU # VASC1694; 66. LHK, Medline SKU # VASC1805; 67. TVR, Medline SKU # VASC1816. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoMedline Industries, LP device recall (Cls I)

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoSpacelabs Healthcare, Inc. device recall (Cls II)HCA Healthcare, Inc.

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor — Reason: Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026device recall169d agoCardinal Health 200, LLC device recall (Cls II)CARDINAL HEALTH INC

    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 — Reason: The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 27, 2026grant169d agoUNIVERSITY OF KANSAS LAWRENCE — Antivirulence activity of skin microbiome-derived small molecules against Sta...Vincere Biosciences Inc

    GM grant. $205,995. PI: ROSANA BARRETO ROCHA FERREIRA

    full page →nih reporter ↗
    ›Feb 27, 2026grant169d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — A Scalable and Effective Digital Behavioral Intervention for Mitigating Hypog...

    DK grant. $780,220. PI: YU KUEI LIN

    full page →nih reporter ↗
    ›Feb 27, 2026grant169d agoDREXEL UNIVERSITY — Dopamine D1-like receptor stimulation promotes HIV neuroimmune pathogenesis i...

    DA grant. $50,196. PI: Yash Dinesh Agarwal

    full page →nih reporter ↗
    ›Feb 28, 2026device pma168d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: SAZ. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Feb 28, 2026grant168d agoCOLUMBIA UNIVERSITY HEALTH SCIENCES — Investigating and targeting oxidative stress and ferroptosis in frontotempora...

    AG grant. $51,492. PI: Julie J. McInvale

    full page →nih reporter ↗
    ›Mar 1, 2026grant167d agoGEORGE WASHINGTON UNIVERSITY — George Washington University-University of Sciences, Techniques and Technolog...

    TW grant. $124,785. PI: SEYDOU DOUMBIA

    full page →nih reporter ↗
    ›Mar 1, 2026grant167d agoICAHN SCHOOL OF MEDICINE AT MOUNT SINAI — Maternal Childhood Maltreatment-Influenced Prenatal Programming of Early Brai...

    HD grant. $249,000. PI: Vanessa Babineau

    full page →nih reporter ↗
    ›Mar 1, 2026grant167d agoMODULO BIO, INC. — Developing an AI-Guided Triculture Platform to Model NeuroHIV specific Microg...

    MH grant. $1,479,470. PI: Steven A Schaffert

    full page →nih reporter ↗
    ›Mar 1, 2026grant167d agoFLORIDA STATE UNIVERSITY — Healthy Choices to Reduce Stigma and Improve Self-Management of Alcohol and H...

    TW grant. $616,000. PI: Henna Budhwani

    full page →nih reporter ↗
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