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calendar

1,343 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 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: 1 catalyst2026-10-01: 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 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device pma×from 2025-09-04×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,587
  • device 510k1,933
  • device recall1,543
  • device pma1,343
device adverse event
1,000
  • earnings585
  • recall534
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 1, 2025

    28
    ›Sep 4, 2025device pma360d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoMedtronic, Inc. — Sphere-9™ Mapping and Ablation Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoLutonix — Lutonix 018 (Model 9014) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoETHICON, Inc. — GYNECARE INTERCEED™ Absorbable Adhesion Barrier (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoVentana Medical Systems, Inc. — CINtec PLUS Cytology (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoBoston Scientific Corp — WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 4, 2025device pma360d agoLutonix — Lutonix 035 (Model 9004 and Model 9010) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoIllumina, Inc. — TruSight Oncology Comprehensive (PMA supplement)ILLUMINA, INC.

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoABBOTT MEDICAL — AVEIR Leadless Pacemaker (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoKeri Medical SA — TOUCH® CMC 1 Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Harmony™ TPV System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Neuromodulation — InterStim® Therapy System; Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Neuromodulation — Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoThe Straumann Company — Straumann Emdogain (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NQA. Advisory committee: DE. Decision: OK30

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d 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); Az (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoKeri Medical SA — TOUCH® CMC 1 Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoLivaNova USA, Inc. — VNS Therapy System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: LYJ. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Aurora EV-ICD System (DVEA3E4) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Neuromodulation — InterStim® Therapy System; Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic Cardiac Rhythm Disease Management — Percepta Bipolar CRT-P W1TR1; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P W (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 5, 2025device pma359d agoMedtronic, Inc. — Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera 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 ↗
    ›Sep 5, 2025device pma359d agoPhilips Medical Systems — HeartStart FRx Defibrillator and HeartStart SMART Pads II (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 7, 2025device pma357d agoABBOTT MEDICAL — Liberta RC™ DBS IPG (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 7, 2025device pma357d agoABBOTT MEDICAL — Eterna™ SCS IPG (PMA supplement)

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

    full page →fda device pma ↗

    Week of Sep 8, 2025

    22
    ›Sep 8, 2025device pma356d agoFerrosan Meidcal Devices A/S — SURGIFOAM® Absorbable Gelatin Sponge (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 8, 2025device pma
    ← prev
    page 1 of 27
    next →
    356d ago
    Croma-Pharma GmbH — saypha® MagIQ™ (PMA)

    Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Sep 8, 2025device pma356d agoOrganox Limited — OrganOx metra® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d 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 ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoIntegra Lifesciences Corp. — INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoETHICON, Inc. — SURGICEL BRAND ABSORBABLE HEMOSTAT (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoMedtronic Cardiac Rhythm Disease Management — Cardiac Resynchronization Therapy -Defibrillator (CRT-D) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoEdwards Lifesciences, LLC — PASCAL Precision Transcatheter Valve Repair System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Iliac Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoWomed Sas — Womed Leaf Resorbable Adhesion Barrier (PMA)

    Product code: MCN. Advisory committee: OB. Decision: APPR

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoMedtronic Cardiac Rhythm Disease Management — Implantable Cardioverter Defibrillator (ICD) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — GORE® TAG® Thoracic Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — Conformable GORE® TAG® Thoracic Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d 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 ↗
    ›Sep 10, 2025device pma354d agoABBOTT MEDICAL — CardioMEMSTM HF System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoBeaver Visitec International, Inc. — FINEVISION HP Trifocal IOLs (PMA)

    Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

    Supplement type: Panel Track. Product code: MAQ. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    $MMSI90.49+1.06%
    $MDT91.23+1.40%
    $ILMN227.69+1.27%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $BSX46.84+0.36%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $MDT91.23+1.40%
    $JNJ268.04+0.85%
    $JNJ268.04+0.85%
    $EW91.33-2.47%
    $IART16.85-0.18%