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calendar

1,788 catalysts · 4,728 grant · 3,189 8k filing · 2,693 approval · 2,565 device 510k · 2,000 device recall · 1,788 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 19 catalysts2026-08-14: 4 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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type: device pma×from 2025-06-24×clear all
type
  • grant4,728
  • 8k filing3,189
  • approval2,693
  • device 510k2,565
  • device recall2,000
  • device pma1,788
device adverse event
1,000
  • recall667
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 23, 2025

    41
    ›Jun 24, 2025device pma415d agoDePuy Orthopaedics, Inc. — CERAMAX® ceramic total hip system (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Jun 24, 2025device pma415d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Jun 24, 2025device pma415d agoABBOTT MEDICAL — Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 24, 2025device pma415d agoABBOTT MEDICAL — Eterna™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 24, 2025device pma415d agoBiomet Manufacturing Corp — OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Jun 24, 2025device pma415d agoStryker Neurovascular — Neuroform Atlas® Stent System (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: QCA. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoBoston Scientific Corp — VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoBiotronik Nro, Inc. — Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

    Supplement type: Real-Time Process. Product code: MOM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoNeuros Medical, Inc. — Altius Direct Electrical Nerve Stimulation System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: SAZ. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoAllergan — Juvederm Injectable Gel (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoABBOTT MEDICAL — MitraClip™ G4 Clip Delivery System; MitraClip™ NTR Clip Delivery System; MitraClip™ XTR Clip Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoSyncardia Systems, LLC — Total Artificial Heart (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: LOZ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoABBOTT MEDICAL — TriClip™ G4 Delivery System; MitraClip™ G5 Delivery System, TriClip™ G5 Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic — HeartWare­™ Ventricular Assist System (HVAD) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Freestyle Bioprosthesis, Models 995, 995CS, 995MS (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoBoston Scientific Corporation — Ranger™ Paclitaxel-Coated PTA Balloon Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 135 Review Track For 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoEdwards Lifesciences, LLC — 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 ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic Vascular — Resolute Onyx (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic Vascular, Inc. — EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoBiosense Webster, Inc. — VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoVeryan Medical, Ltd. — BioMimics 3D Vascular Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Mosaic Bioprosthesis, Models 305, 310 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Hancock II Bioprosthesis, Models T505, T510 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoC.R. Bard, Inc. — Covera™ Vascular Covered Stents (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic, Inc. — CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 PHARMDX (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Product code: PLS. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

    Supplement type: Real-Time Process. Product code: NXW. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — MAGE-A4 IHC 1F9 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Product code: SBL. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators (PMA supplement)

    Supplement type: Real-Time Process. Product code: QMG. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — PD-L1 IHC 28-8 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoTempus Labs, Inc. — xT CDx (PMA supplement)Tempus AI, Inc.

    Supplement type: Real-Time Process. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗

    Week of Jun 30, 2025

    9
    ›Jun 30, 2025device pma409d agoPhysio-Control, Inc. — LIFEPAK FLEX™ Lithium-ion Battery (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 30, 2025device pma
    ← prev
    page 1 of 36
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    409d ago
    Baxter Healthcare Corp — FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (PMA supplement)Baxter Healthcare Corp

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

    full page →fda device pma ↗
    ›Jun 30, 2025device pma409d agoNevro Corporation — Nevro Corp Senza Spinal Cord Stimulation (SCS) System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 30, 2025device pma409d agoTherakos Development Limited — THERAKOS® CELLEX® Photopheresis System Procedural Kit (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoOrganox Limited — OrganOx metra System (PMA supplement)

    Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoSirtex Medical, Inc. — SIR-Spheres Y-90 resin microspheres (PMA supplement)

    Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoCook Ireland, Ltd. — Zilver Flex(R) 35 Vascular Stent (PMA supplement)

    Supplement type: Panel Track. Product code: NIP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

    Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoBoston Scientific Corp — AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    $EW91.33-2.47%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $BSX51.42+0.45%
    $BSX51.42+0.45%
    $BSX51.42+0.45%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $EW91.33-2.47%
    $MDT90.76+0.09%
    $A148.24-0.84%
    $A148.24-0.84%
    $MDT90.76+0.09%
    $TEM
    $A148.24-0.84%
    $TMDX69.43-2.72%
    $MDT90.76+0.09%
    $BSX51.42+0.45%