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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Sep 22, 2025

    28
    ›Sep 22, 2025device pma305d agoBoston Scientific — Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 22, 2025device pma305d agoBoston Scientific Corp — Accolade Non-MRI Pacemakers ALTRUA™ 2 (Models S701, S702, S722); ESSENTIO™ (Models L100, L101, L121); PROPONENT™ (Models (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 23, 2025device pma304d agoMedtronic Vascular, Inc. — VenaSeal™ Closure System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 23, 2025device pma304d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

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

    full page →fda device pma ↗
    ›Sep 23, 2025device pma304d agoMedtronic Vascular, Inc. — Abre Venous Self-expanding Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 23, 2025device pma304d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d agoAbiomed, Inc. — Impella CP with SmartAssist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d agoFarapulse, Inc. — FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d agoABBOTT MEDICAL — CardioMEMS HF System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d agoAbbott Molecular, Inc. — Alinity m HBV (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d 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 24, 2025device pma303d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d agoABBOTT MEDICAL — AVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 24, 2025device pma303d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 25, 2025device pma302d agoEdwards Lifesciences, LLC — Edwards 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 ↗
    ›Sep 25, 2025device pma302d agoABBOTT MEDICAL — DBS Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 25, 2025device pma302d agoABBOTT MEDICAL — SCS Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 25, 2025device pma302d agoABBOTT MEDICAL — DRG Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 25, 2025device pma302d agoGuardant Health, Inc. — Guardant360 CDx (PMA supplement)Guardant Health, Inc.

    Supplement type: Panel Track. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoABBOTT MEDICAL — Infinity™ DBS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoABBOTT MEDICAL — Proclaim™ SCS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoMedtronic Vascular, Inc. — VenaSeal Closure System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoQ-Med AB — Restylane® Injectable Gel (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoABBOTT MEDICAL — Proclaim™ DRG System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d 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 26, 2025device pma301d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗
    ›Sep 26, 2025device pma301d agoQ-Med AB — Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour (PMA supplement)

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

    full page →fda device pma ↗

    Week of Sep 29, 2025

    22
    ›Sep 29, 2025device pma298d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma
    ← prev
    page 17 of 40
    next →
    298d ago
    Physio-Control, Inc. — LIFEPACK® CR2 Automated External Defibrillator (AED) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma298d 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 29, 2025device pma298d agoZOLL Medical Corporation — ZOLL Zenix® Monitor/Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma298d agoHeartsine Technologies, Ltd. — HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (PMA supplement)TAT TECHNOLOGIES LTD

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma298d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma298d agoBard Peripheral Vascular, Inc. — LifeStream™ Balloon Expandable Vascular Covered Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma298d agoInspire Medical Systems — Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Sep 30, 2025device pma297d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05W(A) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 30, 2025device pma297d agoBausch & Lomb, Inc. — Akreos Posterior Chamber Intraocular Lens (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Sep 30, 2025device pma297d agoABBOTT MEDICAL — AVEIR™ Leadless Pacemaker Real-time Clock (RTC) electrical test (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 30, 2025device pma297d agoABBOTT MEDICAL — TriClip™ G4 Delivery System; TriClip™ G5 Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 30, 2025device pma297d 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 30, 2025device pma297d agoABBOTT MEDICAL — MitraClip™ G4 Clip Delivery System; MitraClip™ G5 Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoAbiomed, Inc. — Impella 5.5 with SmartAssist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoBiotronik, Inc. — Ilivia 7 VR-T DX; Intica 7 VR-T DX; Intica 5 VR-T DX; Ilivia 7 VR-T; Ilivia 7 DF4 VR-T; Intica 7 VR-T; Intica 7 DF4 VR-T (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoKARL STORZ Endoscopy-America, Inc. — Photodynamic Diagnostic D-Light C System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoBiotronik, Inc. — Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoBiotronik, Inc. — Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 1, 2025device pma296d agoRayner Intraocular Lenses , Ltd. — Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 2, 2025device pma295d agoEdwards Lifesciences, LLC — PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    $BSX43.58+1.42%
    $GH131.78+2.07%
    $EW91.33-2.47%
    $BSX43.58+1.42%
    $GH131.78+2.07%
    $TATT
    $INSP42.44+0.38%
    $BLCO15.98+0.19%
    $EW91.33-2.47%