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2,005 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: drug expiry×type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,387
  • device pma2,000
device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area
    • Infectious Disease5
    • Oncology1
    • Pulmonology1

    Week of May 26, 2025

    38
    ›May 28, 2025device pma422d agoBoston Scientific Corp — AMS 700™ Inflatable Penile Prosthesis 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 ↗
    ›May 28, 2025device pma422d agoVistakon, Division of Johnson & Johnson Vision Car — VISTAKON® (senofilcon A) Brand Contact Lenses (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoCerenovus, Inc. — TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoFerring Pharmaceuticals, Inc. — EUFLEXXA (1% SODIUM HYALURONATE) (PMA supplement)Ferring Pharmaceuticals Inc

    Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoColoplast Corp. — Titan Inflatable Penile Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoBoston Scientific Corp — AMS 800™ Artificial Urinary Sphincter (AUS) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoCordis US Corporation — S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoIrvine Biomedical, Inc. — IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (PMA supplement)RNR BioMedical Inc

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

    full page →fda device pma ↗
    ›May 28, 2025device pma422d agoBoston Scientific Corp — ROTAPRO™ Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›May 29, 2025device pma421d agoPremia Spine, Ltd. — TOPS™ System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QWK. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›May 29, 2025device pma421d agoNuvasive, Inc. — Simplify® Cervical Artificial Disc (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›May 29, 2025device pma421d 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 ↗
    ›May 29, 2025device pma421d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 29, 2025device pma421d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma421d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma421d agoJohnson & Johnson Surgical Vision, Inc. — Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›May 29, 2025device pma421d agoBoston Scientific Corp — VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d 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 ↗
    ›May 30, 2025device pma420d agoInspire Medical Systems — INSPIRE II UPPER AIRWAY STIMULATOR (PMA supplement)Inspire Medical Systems, Inc.

    Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoMedtronic, Inc. — Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoZoll Manufacturing Corporation — WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d 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 ↗
    ›May 30, 2025device pma420d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoBausch & Lomb, Inc. — enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoCook, Inc. — Zenith® Iliac Branch (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoBausch & Lomb, Inc. — enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoZoll Manufacturing Corporation — WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoZOLL Medical Corporation — AED 3 Semi-Automatic, AED 3 Fully Automatic (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d 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 ↗
    ›May 30, 2025device pma420d agoAlcon Research, LLC — Hydrus® Microstent (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoZOLL Medical Corporation — AED 3 BLS (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoStryker Neurovascular — Surpass Streamline Flow Diverter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoMedtronic, Inc. — HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma420d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

    full page →fda device pma ↗

    Week of Jun 2, 2025

    12
    ›Jun 2, 2025device pma417d agoSirtex Medical, Inc. — Lava Liquid Embolic System (Lava LES) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 2, 2025device pma
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    417d ago
    Organox Limited — OrganOx metra® System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 2, 2025device pma417d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma416d agoBoston Scientific Corp — AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma416d agoInspire Medical Systems — Inspire Upper Airway Stimulation (UAS) (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma416d agoInsightec — Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 3, 2025device pma416d agoCardiovascular Systems, Inc. — Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma415d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma415d agoBoston Scientific Corp — NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma415d agoNovocure, GmbH — Optune Lua (PMA supplement)NovoCure Ltd

    Supplement type: 30-Day Notice. Product code: SDA. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Jun 4, 2025device pma415d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma415d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    $BSX43.58+1.42%
    $JNJ259.27+1.42%
    $MDT82.01+0.15%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $JNJ259.27+1.42%
    $BSX43.58+1.42%
    $MDT82.01+0.15%
    $INSP42.44+0.38%
    $MDT82.01+0.15%
    $MDT82.01+0.15%
    $MDT82.01+0.15%
    $BLCO15.98+0.19%
    $BLCO15.98+0.19%
    $IGC0.2670+0.41%
    $MDT82.01+0.15%
    $BSX43.58+1.42%
    $NVCR20.05+28.74%
    $INSP42.44+0.38%
    $BSX43.58+1.42%