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calendar

503 catalysts · 3,062 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 583 earnings

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2026-08-10: 0 catalysts2026-08-11: 33 catalysts2026-08-12: 19 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: 2 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 2026-01-30×clear all
type
  • 8k filing3,062
  • grant2,029
  • device adverse event1,000
  • approval897
  • device 510k659
  • earnings583
device pma
503
  • device recall211
  • phase 2 completion172
  • recall167
  • therapy area

    no tagged catalysts yet

    Week of Jan 26, 2026

    6
    ›Jan 30, 2026device pma193d 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 ↗
    ›Jan 30, 2026device pma193d agoBoston Scientific Corp — Eluvia Drug-Eluting Vascular Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 30, 2026device pma193d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 30, 2026device pma193d 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 pma193d 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 pma193d 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 pma190d 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

    4
    ›Feb 9, 2026device pma183d 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 1 of 11
    next →
    190d 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 pma190d 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 pma190d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma189d 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 pma188d 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 pma188d 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 pma188d 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 pma188d 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 pma188d 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 pma188d 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 pma188d 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 pma188d 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 pma188d 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 pma187d 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 pma187d 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 pma187d 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 pma187d 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 pma187d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 pma186d 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 ↗
    183d 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 pma182d 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 pma182d 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 ↗
    $BSX50.46+2.33%
    $MMSI89.75+0.80%
    $INSP42.44+0.38%
    $MDT89.41+2.58%
    $EW91.33-2.47%
    $EW91.33-2.47%
    $MDT89.41+2.58%
    $EW91.33-2.47%
    $MDT89.41+2.58%
    $RCEL7.6000-2.19%
    $MDT89.41+2.58%
    $IGC0.2670+0.41%
    $EW91.33-2.47%
    $GH131.78+2.07%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $INSP42.44+0.38%