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calendar

930 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma

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type: device pma×from 2025-11-03×clear all
type
  • 8k filing3,603
  • grant2,377
  • approval2,049
  • device 510k1,383
  • device adverse event1,000
  • device pma930
device recall
912
  • earnings585
  • recall364
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 3, 2025

    21
    ›Nov 3, 2025device pma299d agoBeckman Coulter, Inc. — Access AFP (on DxI 9000 Analyzer) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LOK. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoQ-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

    Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoMedtronic Neuromodulation — nterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (LVAS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

    Supplement type: Real-Time Process. Product code: LMG. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Nov 4, 2025device pma298d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 5, 2025device pma297d agoPromega Corporation — OncoMate® MSI Dx Analysis System (PMA)

    Product code: SFL. Advisory committee: MG. Decision: APPR

    full page →fda device pma ↗
    ›Nov 6, 2025device pma296d agoNyxoah S.A. — Genio® System 2.1 (PMA supplement)Nyxoah SA

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma296d agoStryker Leibinger GmbH & Co KG — Adherus AutoSpray Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma296d agoPhysio-Control, Inc. — LIFEPAK® CR2 Automated External Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma296d agoBoston Scientific Corp — WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoABBOTT MEDICAL — Dorsal Root Ganglion (DRG) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoABBOTT MEDICAL — Spinal Cord Stimulation (SCS) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoPramand, LLC — SpineSeal™ Spine Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoMedtronic Vascular, Inc. — EverFlex self-expanding Peripheral Stent System (EverFlex) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoIntersect Ent. — Propel Contour Sinus Implant (PMA supplement)

    Supplement type: Real-Time Process. Product code: OWO. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoABBOTT MEDICAL — Deep Brain Stimulation (DBS) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma295d agoMedtronic Vascular, Inc. — Protégé GPS self-expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 8, 2025device pma294d agoSaluda Medical Pty, Ltd. — Saluda Medical Evoke® SCS System (PMA supplement)

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

    full page →fda device pma ↗

    Week of Nov 10, 2025

    12
    ›Nov 10, 2025device pma292d agoMedtronic, Inc. — Hancock II Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma

    Week of Nov 17, 2025

    17
    ›Nov 18, 2025device pma284d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 18, 2025device pma
    ← prev
    page 1 of 19
    next →
    292d ago
    ABBOTT MEDICAL — CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma292d agoMedtronic, Inc. — Freestyle Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma292d agoMedtronic, Inc. — Mosaic Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma292d agoMedtronic, Inc. — Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 12, 2025device pma290d agoGraphic Controls D.B.A. Vermed — HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma289d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma289d agoMedtronic, Inc. — SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Nov 13, 2025device pma289d agoBaxter Healthcare Corp — Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (PMA supplement)Baxter Healthcare Corp

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma289d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 14, 2025device pma288d agoAtriCure, Inc. — EPi-Sense ST Coagulation System (PMA supplement)AtriCure, Inc.

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

    full page →fda device pma ↗
    ›Nov 14, 2025device pma288d agoSTAAR Surgical Company — VISIAN ICL (IMPLANTABLE COLLAMER LENS) (PMA supplement)STAAR SURGICAL CO

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

    full page →fda device pma ↗
    284d ago
    Philips Image Guided Therapy Corporation — Duo Venous Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 18, 2025device pma284d agoMentor Worldwide, LLC — MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (PMA supplement)Revalesio Corp

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

    full page →fda device pma ↗
    ›Nov 19, 2025device pma283d agoLife Technologies Corporation — Oncomine Dx Target Test (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 19, 2025device pma283d agoEdwards Lifesciences, LLC — EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Nov 19, 2025device pma283d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 19, 2025device pma283d agoImpulse Dynamics (Usa), Inc. — OPTIMIZER SMART Mini IPG (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 19, 2025device pma283d agoSyncardia Systems, LLC — Total Artificial Heart (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoMedtronic, Inc. — Sphere-9 TM Mapping and Ablation Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoTiger Aesthetics Medical, LLC — Sientra Silicone Gel Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoABBOTT MEDICAL — IsoFlex™ Pacing Leads (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoIntegrum AB — OPRA Implant System, Abutment component (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoABBOTT MEDICAL — Quartet™ and QuickFlex™ µ Left Heart Leads (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoMedibeacon, Inc. — MediBeacon® Transdermal GFR Measurement System (GFR) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoABBOTT MEDICAL — Durata™ Defibrillation Leads (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoABBOTT MEDICAL — Tendril™ MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 20, 2025device pma282d agoABBOTT MEDICAL — OptiSense™ Pacing Leads (PMA supplement)

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

    full page →fda device pma ↗
    $NYXH
    $BSX47.53-1.33%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $ATRC
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $STAA22.11-1.25%
    $MDT91.23+1.40%
    $EW91.33-2.47%