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calendar

1,743 catalysts · 4,728 grant · 3,189 8k filing · 2,681 approval · 2,488 device 510k · 2,000 device recall · 1,743 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 2025-07-01×clear all
type
  • grant4,728
  • 8k filing3,189
  • approval2,681
  • device 510k2,488
  • device recall2,000
  • device pma1,743
device adverse event
1,000
  • recall663
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 30, 2025

    34
    ›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 ↗
    ›Jul 1, 2025device pma408d 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 ↗
    ›Jul 2, 2025device pma407d agoMedtronic, Inc. — MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoAbbott Vascular — RX HERCULINK ELITE RENAL STENT SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoABBOTT MEDICAL — Proclaim DRG IPG (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoMedtronic Cardiac Rhythm Disease Management — VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoABBOTT MEDICAL — Infinity DBS IPG (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoBecton, Dickinson and Company — BD Onclarity HPV Assay (PMA supplement)BECTON DICKINSON & CO

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoLife Technologies Corporation — Oncomine Dx Express Test (PMA)

    Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoABBOTT MEDICAL — Aveir VR and DR Delivery Catheters (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoABBOTT MEDICAL — Proclaim SCS IPG (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoMedtronic, Inc. — MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoMedtronic, Inc. — MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 2, 2025device pma407d agoMedtronic Cardiac Rhythm Disease Management — CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoCochlear Americas — Nucleus® 22 Cochlear Implant System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoCochlear Americas — Nucleus® Hybrid™ L24 Cochlear Implant System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: PGQ. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoCochlear Americas — Nucleus® 24 Auditory Brainstem Implant System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MHE. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d 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 ↗
    ›Jul 3, 2025device pma406d agoDefibtech, LLC — Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoCook Ireland, Ltd. — Zilver® PTX® Peripheral Drug-Eluting Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoInsightec — Exablate Model 4000 Type-1 System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoMentor Corp. — MENTOR MemoryGel Enhance Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d agoCochlear Americas — Nucleus® 22 Cochlear Implant System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Jul 3, 2025device pma406d 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 ↗

    Week of Jul 7, 2025

    16
    ›Jul 7, 2025device pma402d 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 ↗
    ›Jul 7, 2025device pma
    ← prev
    page 1 of 35
    next →
    402d ago
    Atrium Medical Corp. — iCast Covered Stent System (PMA supplement)Apyx Medical Corp

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

    full page →fda device pma ↗
    ›Jul 8, 2025device pma401d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jul 8, 2025device pma401d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic, Inc. — Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoBausch & Lomb, Inc. — Akreos Posterior Chamber Intraocular Lens (IOL) (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic, Inc. — Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD, Cobalt XT MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoFerrosan Meidcal Devices A/S — SURGIFLO™ Hemostatic Matrix Kit with Thrombin (PMA supplement)PFIZER INC

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic, Inc. — Epsila EV Extravascular Lead EV2401 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)DFB Soria LLC

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoLimFlow, Inc. — LimFlow System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jul 9, 2025device pma400d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)DFB Soria LLC

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

    full page →fda device pma ↗
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $IGC0.2670+0.41%
    $MDT90.76+0.09%
    $BDX183.58+1.20%
    $TMDX69.43-2.72%
    $BSX51.42+0.45%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $EW91.33-2.47%
    $APYX
    $EW91.33-2.47%
    $MDT90.76+0.09%
    $BLCO16.76-0.65%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $MDT90.76+0.09%
    $PFE26.31-1.16%