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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 Nov 10, 2025

    3
    ›Nov 13, 2025device pma254d 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 pma253d 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 pma253d 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 ↗

    Week of Nov 17, 2025

    23
    ›Nov 18, 2025device pma249d 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

    Week of Nov 24, 2025

    23
    ›Nov 24, 2025device pma243d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma

    Week of Dec 1, 2025

    1
    ›Dec 1, 2025device pma236d agoBoston Scientific Corp — WOLVERINE™ Coronary Cutting Balloon™ (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ← prev
    page 23 of 40
    next →
    249d 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 pma249d 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 pma248d 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 pma248d 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 pma248d 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 pma248d 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 pma248d 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 pma247d 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 pma247d 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 pma247d 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 pma247d 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 pma247d 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 pma247d 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 pma247d 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 pma247d 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 pma247d 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 ↗
    ›Nov 21, 2025device pma246d agoLife Technologies Corporation — Oncomine™ Dx Target Test (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 21, 2025device pma246d agoTherakos Development Limited — THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 21, 2025device pma246d agoGE Healthcare — Senographe Pristina 3D (PMA supplement)HCA Healthcare, Inc.

    Supplement type: Normal 180 Day Track. Product code: OTE. Advisory committee: RA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 21, 2025device pma246d agoQiagen — QuantiFERON-TB Gold Plus Test (PMA supplement)QIAGEN N.V.

    Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Nov 21, 2025device pma246d agoPhysio-Control, Inc. — LIFEPAK® 35 monitor/defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 22, 2025device pma245d agoMedtronic, Inc. — Medtronic DBS Therapy for Dystonia (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    243d ago
    Hologic, Inc. — Envision Mammography Platform (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma243d agoThe Spectranetics Corp. — Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma243d agoExact Sciences Corporation — Cologuard® (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma243d agoOcclutech Holding AG — Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoMicroPort CRM USA, Inc. — ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoEndotronix, Inc. — CorPASS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoMicroPort CRM USA, Inc. — ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoLivaNova USA, Inc. — VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoMicroPort CRM USA, Inc. — ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoMedtronic, Inc. — Micra Transcatheter Pacing Systems (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoInstylla, Inc. — Embrace(TM) Hydrogel Embolic System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoXvivo Perfusion, Inc. — XPS™ with Steen Solution™ Perfusate (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma242d agoLumicell, Inc. — Lumicell Direct Visualization System (DVS) (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: SAW. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d 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 ↗
    ›Nov 26, 2025device pma241d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d agoMed-El Corp. — MED-EL CI System (PMA supplement)

    Supplement type: Panel Track. Product code: MCM. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Nov 26, 2025device pma241d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Ve (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 28, 2025device pma239d agoCleveland Diagnostics, Inc. — IsoPSA Assay (PMA)Co-Diagnostics, Inc.

    Product code: QRF. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    $STAA23.58-2.52%
    $BSX44.25+1.54%
    $ATRC
    $MDT83.11+1.35%
    $MDT83.11+1.35%
    $QGEN
    $EW91.33-2.47%
    $MDT83.11+1.35%
    $HCA382.19+1.51%
    $MDT83.11+1.35%
    $MDT83.11+1.35%
    $CODX2.1000-4.98%