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calendar

12,031 catalysts · 3,350 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 0 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
  • grant2,283
  • approval1,778
  • device 510k1,169
  • device adverse event1,000
  • device pma849
device recall
655
  • earnings584
  • recall282
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 15, 2025

    50
    ›Dec 16, 2025device pma243d agoVistakon, Division of Johnson & Johnson Vision Car — VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (PMA supplement)JOHNSON & JOHNSON

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoC.R. Bard, Inc. — Covera™ Vascular Covered Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

    Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoJohnson & Johnson Surgical Vision, Inc. — Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht (PMA supplement)JOHNSON & JOHNSON

    Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoMedtronic Vascular, Inc. — Protégé™ GPS™ Self-expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoBausch & Lomb — Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) (PMA supplement)Bausch & Lomb Corp

    Supplement type: 30-Day Notice. Product code: MWL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoCerenovus, Inc. — TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set (PMA supplement)

    Supplement type: Panel Track. Product code: SGU. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoTransMedics, Inc. — Organ Care System™ (OCS™) Lung System (PMA supplement)TransMedics Group, Inc.

    Supplement type: Special (Immediate Track). Product code: QBA. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoTransMedics, Inc. — Organ Care System™ (OCS™) Heart (PMA supplement)TransMedics Group, Inc.

    Supplement type: Special (Immediate Track). Product code: QIK. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS SIMPLICITY™ Delivery System (PMA supplement)JOHNSON & JOHNSON

    Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Dec 16, 2025device pma243d agoVistakon, Johnson & Johnson Vision Products, Inc. — ACUVUE CONTACT LENS (PMA supplement)JOHNSON & JOHNSON

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

    Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

    Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927. — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Surgical TID Pharos Illuminated Depressor, VS0801B — Reason: XXX — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Surgical I2 Injection Kit, VS0500 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

    Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017. — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing

    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Tecfen Retractable Membrane Polisher, QTPR1267-23 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    25GA Subretinal Injection Cannula VS0220.25 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

    Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359 — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

    Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924. — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing

    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025device recall243d agoMedline Industries, LP device recall (Cls II)Revalesio Corp

    Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G. — Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. — Status: Ongoing

    ›Dec 16, 2025device recall243d agoVortex Surgical Inc. device recall (Cls II)

    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker — Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. — Status: Ongoing

    full page →fda device recalls ↗
    ›Dec 16, 2025grant243d agoUNIVERSITY OF WASHINGTON — Landscape Immunity, Climate, and Yellow Fever RiskUniversity of Washington

    AI grant. $47,459. PI: Hilary McLeland-Wieser

    full page →nih reporter ↗
    ›Dec 17, 2025approval242d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

    Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →eplontersen sodium →fda approvals ↗
    ›Dec 17, 2025approval242d agoZYNYZ (RETIFANLIMAB-DLWR) — FDA approvalretifanlimab

    Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS

    full page →retifanlimab →fda approvals ↗
    ›Dec 17, 2025approval242d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

    Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 17, 2025approval242d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 17, 2025approval242d agoGAZYVA (OBINUTUZUMAB) — FDA approvalobinutuzumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →obinutuzumab →fda approvals ↗
    ›Dec 17, 2025approval242d agoBORTEZOMIB — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: SHUANGCHENG. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 17, 2025approval242d agoLATANOPROST — FDA approvalXalatan

    Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Xalatan →fda approvals ↗
    ›Dec 17, 2025approval242d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →VINCRISTINE SULFATE PFS →fda approvals ↗
    ›Dec 17, 2025approval242d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: GRANULES. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 2025approval242d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →elagolix sodium →fda approvals ↗
    ›Dec 17, 2025approval242d agoRYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ) — FDA approval(amivantamab + hyaluronidase (human recombinant))

    Sponsor: JANSSEN BIOTECH. Form: INJECTION

    full page →(amivantamab + hyaluronidase (human recombinant)) →fda approvals ↗
    ›Dec 17, 2025approval242d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

    Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

    full page →rucaparib camsylate →fda approvals ↗
    ›Dec 17, 2025approval242d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

    Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

    full page →rucaparib camsylate →fda approvals ↗
    ›Dec 17, 2025approval242d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalBayer HealthCare Pharmaceuticals Inc

    Sponsor: UNIQUE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 17, 2025approval242d agoTESTOSTERONE — FDA approvalTransdermal Delivery Solutions Corp

    Sponsor: ENCUBE. Form: GEL. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Dec 17, 2025approval242d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →ORIAHNN (COPACKAGED) →fda approvals ↗
    ›Dec 17, 2025approval242d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

    Sponsor: PFIZER INC. Form: INJECTABLE. Route: INJECTION

    full page →ABRILADA →fda approvals ↗
    ›Dec 17, 2025approval242d agoTRAVOPROST — FDA approvalTRAVOPROST

    Sponsor: ALEMBIC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →TRAVOPROST →fda approvals ↗
    ›Dec 17, 2025approval242d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

    Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

    full page →tralokinumab →fda approvals ↗
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