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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Jan 5, 2026

    13
    ›Jan 8, 2026device pma199d agoDePuy Orthopaedics, Inc. — Ceramax® Ceramic Total Hip System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoCordis US Corporation — PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoBoston Scientific Corporation — ENROUTE Transcarotid Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoSt Jude Medical — TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoHeartsine Technologies, Ltd. — HeartSine’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (PMA supplement)TAT TECHNOLOGIES LTD

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoBoston Scientific Corp — NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoCordis US Corporation — S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent System; S.M.A.R.T. RADIANZ™ Vascular Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoAlcon Research, LLC — UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoABBOTT MEDICAL — FlexAbility™ Ablation Catheter (Flex) and FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 9, 2026device pma198d agoABBOTT MEDICAL — CardioMEMS™ HF System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 9, 2026device pma198d 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 ↗
    ›Jan 9, 2026device pma198d agoBoston Scientific — INGEVITY™ Family Bradycardia Leads (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 9, 2026device pma198d agoKardium, Inc. — Globe® Catheter; Globe® Pulsed Field System (PMA supplement)Kardigan Inc

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

    full page →fda device pma ↗

    Week of Jan 12, 2026

    37
    ›Jan 12, 2026device pma195d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M; TECNIS 1-Piece I (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma
    ← prev
    page 29 of 40
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    195d ago
    Farapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma195d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge, 13.0 mm, ZA9003 (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma195d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Multi-focal 3-pc, ZMA00 (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma195d agoAbbott Vascular-Cardiac Therapies — Omnilink Elite Vascular Balloon-Expandable Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d 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 ↗
    ›Jan 13, 2026device pma194d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d agoABBOTT MEDICAL — Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d agoABBOTT MEDICAL — Eterna SCS and Proclaim SCS Systems (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d 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 ↗
    ›Jan 13, 2026device pma194d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma194d 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 ↗
    ›Jan 14, 2026device pma193d agoTeoxane S.A. — RHA® Redensity dermal filler (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Jan 14, 2026device pma193d agoCardiovascular Systems, Inc. — Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma193d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma193d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma193d 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 ↗
    ›Jan 14, 2026device pma193d agoAdvanced Medical Solutions Limited — LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma193d 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 ↗
    ›Jan 14, 2026device pma193d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma193d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d 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 ↗
    ›Jan 15, 2026device pma192d 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 ↗
    ›Jan 15, 2026device pma192d agoSt Jude Medical — Livewire™ TC XLS™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d agoCentinel Spine, LLC — prodisc® C (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d agoABBOTT MEDICAL — FlexAbility™ and FlexAbility™ Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d agoMicroPort CRM USA, Inc. — VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d 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 ↗
    ›Jan 15, 2026device pma192d agoABBOTT MEDICAL — TactiFlex™ Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d agoIrvine Biomedical,Inc.(Ibi) — Safire™ TX Bi-directional and Therapy™ Dual-8™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma192d agoSt Jude Medical — TactiCath™ Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma191d agoSetPoint Medical — SetPoint System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma191d agoMedtronic, Inc. — Harmony™ Transcatheter Pulmonic Valve System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma191d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    $JNJ263.40+1.59%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $TATT
    $JNJ263.40+1.59%
    $JNJ263.40+1.59%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $GH131.78+2.07%
    $BSX44.25+1.54%
    $MDT83.21+1.46%