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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Jan 26, 2026

    3
    ›Jan 30, 2026device pma177d agoInspire Medical Systems — QMR Battery Separator Supplier (PMA supplement)Inspire Medical Systems, Inc.

    Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Jan 30, 2026device pma177d agoBalt USA, LLC — SQUID Liquid Embolic Agent (LEA) (PMA)Bayer USA LLC

    Product code: SGU. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jan 30, 2026device pma177d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)DFB Soria LLC

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

    full page →fda device pma ↗

    Week of Feb 2, 2026

    40
    ›Feb 2, 2026device pma174d agoPhilips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Feb 2, 2026device pma

    Week of Feb 9, 2026

    7
    ›Feb 9, 2026device pma167d agoExact Sciences Corporation — Cologuard Plus™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 9, 2026device pma
    ← prev
    page 31 of 40
    next →
    174d ago
    CooperVision, Inc. — Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 2, 2026device pma174d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 2, 2026device pma174d agoPhilips Medical Systems — HeartStart FRx Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoGen-Probe Incorporated — Aptima HPV 16 18/45 Genotype Assay (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: OYB. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoBiotronik, Inc. — PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoABBOTT MEDICAL — TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoGen-Probe Incorporated — APTIMA HPV ASSAY (PMA supplement)

    Supplement type: Panel Track. Product code: OYB. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoBiotronik, Inc. — PHYLAX AV ICD SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoBiotronik, Inc. — DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoAbbott Vascular — XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoBiotronik, Inc. — TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoBiotronik, Inc. — STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma173d agoMedtronic — HeartWare® HVAD System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoInstylla, Inc. — Embrace™ Hydrogel Embolic System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoMedinol, Ltd. — EluNIR™ Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoMentor Corp. — MENTOR™ MemoryGel™ Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoMentor Worldwide, LLC — MENTOR™ MemoryShape™ Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoMentor Worldwide, LLC — MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (PMA supplement)Revalesio Corp

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

    Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoMedtronic, Inc. — Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 4, 2026device pma172d agoMedtronic, Inc. — Avalus™ Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus™ Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 5, 2026device pma171d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 5, 2026device pma171d agoAbbott Vascular (Idef Technologies Inc) — Supera Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 5, 2026device pma171d agoArj Medical, Inc. — PyloPlus UBT System (PMA supplement)AVITA Medical, Inc.

    Supplement type: Normal 180 Day Track. Product code: OZA. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Feb 5, 2026device pma171d agoQ-Med AB — Restylane Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Feb 5, 2026device pma171d agoAbbott Vascular — XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Stent (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoEdwards Lifesciences, LLC — TRIFORMIS RESILIA Tricuspid Valve, Model 11300T (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoEdwards Lifesciences, LLC — TRIFORMIS RESILIA Tricuspid Valve, Model 11300T (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoMedtronic Neuromodulation — Altaviva™ Tibial Neuromodulation System (Altaviva™ P7850N) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoAbiomed, Inc. — Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoSpectranetics Corp. — ELCA Coronary Atherectomy Catheters (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoMedtronic, Inc. — SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (Drug Delivery Infusion Pump 8667) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS, DBS Neurostimulator Implantable, DBS Neuros (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoInspire Medical Systems — INSPIRE II UPPER AIRWAY STIMULATOR (PMA supplement)Inspire Medical Systems, Inc.

    Supplement type: Normal 180 Day Track. Product code: MNQ. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Feb 6, 2026device pma170d agoAbiomed, Inc. — Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    167d ago
    Medtronic Vascular, Inc. — EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d 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 ↗
    ›Feb 10, 2026device pma166d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoAlcon Research, LLC — UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System (PMA supplement)

    Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoMedtronic, Inc. — Micra AV2 TPS; Micra VR2 TPS (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 10, 2026device pma166d agoAlcon Laboratories — VISCOAT™ Ophthalmic Viscosurgical Device (PMA supplement)Alcon Laboratories Inc

    Supplement type: Normal 180 Day Track. Product code: LZP. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    $INSP42.44+0.38%
    $MMSI74.32+1.66%
    $EW91.33-2.47%
    $EW91.33-2.47%
    $RCEL4.61000.00%
    $MDT83.21+1.46%
    $IGC0.2670+0.41%
    $MDT83.21+1.46%
    $GH131.78+2.07%
    $MDT83.21+1.46%
    $EW91.33-2.47%
    $EW91.33-2.47%
    $MDT83.21+1.46%
    $INSP42.44+0.38%
    $MDT83.21+1.46%
    $MDT83.21+1.46%