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calendar

1,501 catalysts · 4,728 grant · 3,062 8k filing · 2,627 approval · 2,156 device 510k · 1,745 device recall · 1,501 device pma

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2026-08-10: 0 catalysts2026-08-11: 33 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: 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 2025-08-08×clear all
type
  • grant4,728
  • 8k filing3,062
  • approval2,627
  • device 510k2,156
  • device recall1,745
  • device pma1,501
device adverse event
1,000
  • recall586
  • earnings583
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 4, 2025

    11
    ›Aug 8, 2025device pma368d agoBoston Scientific Corp — Eluvia™ Drug-Eluting Vascular Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoAbiomed, Inc. — Impella CP with SmartAssist System (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoNyxoah S.A. — Genio® System 2.1 (PMA)Nyxoah SA

    Product code: MNQ. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoMentor Corp. — MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoAbbott Molecular, Inc. — Vysis CLL Fish Probe Kit (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoMentor Worldwide, LLC — MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (PMA supplement)Revalesio Corp

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d 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 ↗
    ›Aug 8, 2025device pma368d agoBoston Scientific Corporation — lnnova™ Vascular Self Expanding Stent (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoMentor Worldwide, LLC — MENTOR™ MemoryShape™ Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 8, 2025device pma368d agoBoston Scientific Corp — Epic™ Vascular Self-Expanding Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗

    Week of Aug 11, 2025

    39
    ›Aug 12, 2025device pma364d 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 ↗
    ›Aug 12, 2025device pma
    ← prev
    page 1 of 31
    next →
    364d ago
    Lenstec, Inc. — Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d 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 ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — IN.PACT 018 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 ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d 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 ↗
    ›Aug 12, 2025device pma364d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoNovocure, GmbH — Optune Lua (PMA supplement)NovoCure Ltd

    Supplement type: Real-Time Process. Product code: SDA. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d 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 ↗
    ›Aug 12, 2025device pma364d agoLenstec, Inc. — ClearView 3 Lens (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD, Cobalt XT MRI ICD, Srome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMentor Worldwide, LLC — MemoryShape™ Silicone Gel-Filled Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMentor Worldwide, LLC — Saline and SPECTRUM™ Saline-Filled Breast Implants (PMA supplement)Revalesio Corp

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d agoMentor Corp. — MemoryGel™ Silicone Gel-Filled Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 12, 2025device pma364d 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;Brav (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma363d agoMedtronic Vascular, Inc. — Protege™ RX Carotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma363d agoAvive Solutions, Inc. — Avive Automated External Defibrillator (AED) System (PMA supplement)Iveda Solutions, Inc.

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma363d agoBard Peripheral Vascular, Inc. — FLUENCY PLUS ENDOVASCULAR STENT GRAFT (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma363d agoEdwards Lifesciences, LLC — Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Aug 13, 2025device pma363d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator, Model 4000 (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoBoston Scientific Corp — Blazer™ Open-Irrigated Ablation Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Pipeline™ Vantage Embolization Device with Shield Technology™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoAllergan — Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm (hereafter ref (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoBoston Scientific Corp — ROTABLATOR™ Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d 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 ↗
    ›Aug 14, 2025device pma362d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoBoston Scientific — Blazer™ II XP Cardiac Ablation Catheter and Cable (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoAllergan — Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra XC and Ultra Plus XC) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoSiemens Medical Solutions Diagnostics Limited — IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoSiemens Healthcare Diagnostics, Inc. — IMMULITE 2000 Prostate-Specific Antigen (PSA) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoColoplast Corp. — Titan Inflatable Penile Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 14, 2025device pma362d agoMedtronic, Inc. — Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    $BSX50.46+2.33%
    $NYXH
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $NVCR20.05+28.74%
    $EW91.33-2.47%
    $MDT89.41+2.58%
    $IVDAW
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $BSX50.46+2.33%