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calendar

1,916 catalysts · 4,728 grant · 3,045 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma

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2026-08-10: 0 catalysts2026-08-11: 16 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: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device pma×from 2025-06-06×clear all
type
  • grant4,728
  • 8k filing3,045
  • device 510k2,737
  • approval2,721
  • device recall2,000
  • device pma1,916
device adverse event
1,000
  • recall686
  • earnings578
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 2, 2025

    3
    ›Jun 6, 2025device pma431d agoSurmodics,Inc. — SurVeil Drug-Coated Balloon (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma431d agoNovocure, GmbH — Optune® (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma431d agoEdwards Lifesciences, LLC — 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 ↗

    Week of Jun 9, 2025

    35
    ›Jun 9, 2025device pma428d agoABBOTT MEDICAL — Liberta RC Deep Brain Stimulation Implantable Pulse Generator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma

    Week of Jun 16, 2025

    12
    ›Jun 16, 2025device pma421d agoBeckman Coulter, Inc. — Access Hybritech p2PSA (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 16, 2025device pma
    ← prev
    page 1 of 39
    next →
    428d ago
    Philips Medical Systems — HeartStart FRx Defibrillator (861304) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma428d agoPhilips Medical Systems, Inc. — HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma428d agoABBOTT MEDICAL — Eterna Spinal Cord Stimulation Implantable Pulse Generator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma428d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma428d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jun 9, 2025device pma428d agoMedtronic Neuromodulation — Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 10, 2025device pma427d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 10, 2025device pma427d agoMedtronic, Inc. — Activa™ and Percept™ Deep Brain Stimulation Therapy System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 10, 2025device pma427d agoDavol Inc., Sub. C. R. Bard, Inc. — Avitene Flowable Collagen Hemostat (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 10, 2025device pma427d 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 ↗
    ›Jun 10, 2025device pma427d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jun 10, 2025device pma427d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 10, 2025device pma427d agoThe Straumann Company — BIORA EMDOGAIN(R) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NQA. Advisory committee: DE. Decision: APPR

    full page →fda device pma ↗
    ›Jun 11, 2025device pma426d agoW. L. Gore & Associates, Inc. — GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 11, 2025device pma426d agoVentana Medical Systems, Inc. — PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 11, 2025device pma426d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 11, 2025device pma426d agoRxsight, Inc. — Light Adjustable Lens, Light Delivery System (PMA supplement)RxSight, Inc.

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

    full page →fda device pma ↗
    ›Jun 11, 2025device pma426d agoLeMaitre Vascular, Inc. — Artegraft Collagen Vascular Graft (PMA supplement)LEMAITRE VASCULAR INC

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoMedtronic Vascular — Endurant Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoRayner Intraocular Lenses , Ltd. — C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma425d agoMedtronic Vascular — Valiant Thoracic Stent Graft with the Captivia Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d 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: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoMedtronic, Inc. — Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma424d agoMedtronic, Inc. — Micra AV TPS MC1AVR1; 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 ↗
    421d ago
    Ventana Medical Systems, Inc. — VENTANA HER2 DualL ISH DNA Probe Cocktail (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 16, 2025device pma421d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 16, 2025device pma421d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jun 16, 2025device pma421d agoMerz North America, Inc. — COAPTITE® (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoMedtronic, Inc. — Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoABBOTT MEDICAL — Microny family of Pacemakers (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base, 24970A (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoABBOTT MEDICAL — Aveir Leadless System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoAtriCure, Inc. — Synergy Ablation System (PMA supplement)AtriCure, Inc.

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma420d agoMedtronic, Inc. — Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    $NVCR20.05+28.74%
    $EW91.33-2.47%
    $MMSI89.75+0.80%
    $CAI
    $JNJ261.81+0.99%
    $MDT89.41+2.58%
    $RXST
    $MMSI89.75+0.80%
    $LMAT81.19-0.32%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MMSI89.75+0.80%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $ATRC
    $MDT89.41+2.58%