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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 Mar 23, 2026

    20
    ›Mar 25, 2026device pma124d agoMedtronic Vascular — Onyx Frontier Zotarolimus Eluting Coronary Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 25, 2026device pma124d agoMedtronic, Inc. — Symplicity Spyral™ Renal Denervation Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Mar 25, 2026device pma124d agoCook Ireland, Ltd. — Zilver® PTX® Drug-Eluting Peripheral Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 26, 2026device pma123d 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 ↗
    ›Mar 26, 2026device pma123d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 26, 2026device pma123d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoMedtronic, Inc. — Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System; Medtronic Evolut (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoBiotronik, Inc. — Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d 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 ↗
    ›Mar 27, 2026device pma122d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoMedtronic, Inc. — Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoABBOTT MEDICAL — Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d agoCardiva Medical, Inc. — VASCADE MVP XL VVCS Model 800-1014XL (PMA supplement)Picard Medical, Inc.

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d 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 ↗
    ›Mar 27, 2026device pma122d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Mar 27, 2026device pma122d 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 ↗
    ›Mar 27, 2026device pma122d agoABBOTT MEDICAL — Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( (PMA supplement)

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

    full page →fda device pma ↗

    Week of Mar 30, 2026

    30
    ›Mar 30, 2026device pma119d agoBiotronik, Inc. — Amvia-Solvia Pulse Generators Scan Duration Extension (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 30, 2026device pma
    ← prev
    page 39 of 40
    next →
    119d ago
    Kaneka Pharma America Corp. — LIPOSORBER® LA-15 System (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 30, 2026device pma119d agoOrganox 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 ↗
    ›Mar 31, 2026device pma118d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

    Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Mar 31, 2026device pma118d agoCordis US Corporation — Mynx Control Vascular Closure Device (5F, 6F/7F) (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 31, 2026device pma118d agoTeoxane S.A. — RHA® Redensity™ Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoCompanion Spine France Sas — DIAM­™ Spinal Stabilization System (PMA supplement)

    Supplement type: Real-Time Process. Product code: NQO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoTeoxane S.A. — RHA® Redensity, RHA® Redensity™ Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi, RHA®4 and RHA® Dynamic Volume (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d 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 ↗
    ›Apr 1, 2026device pma117d agoBoston Scientific Corp — PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoAbbott Vascular, Inc. — Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoBoston Scientific Corp — CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d 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 ↗
    ›Apr 1, 2026device pma117d agoPramand, LLC — SpineSeal Spine Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoAbiomed, Inc. — Impella RP System (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoGuidant Corp. — CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoMicroTransponder, Inc. — Vivistim® Paired VNS™ System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoBoston Scientific — VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoBiotronik, Inc. — PRO-Kinetic Energy Coronary Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoBiotronik, Inc. — ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

    full page →fda device pma ↗
    ›Apr 1, 2026device pma117d agoInstylla, Inc. — Embrace Hydrogel Embolic System (HES) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoEuclid Vision Corporation — Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (LVAS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoInstylla, Inc. — Embrace Hydrogel Embolic System (HES) (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoBecton, Dickinson and Company — BD Onclarity HPV Assay (PMA supplement)BECTON DICKINSON & CO

    Supplement type: Normal 180 Day Track. Product code: MAQ. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoBecton, Dickinson and Company — BD Onclarity HPV Assay (PMA supplement)BECTON DICKINSON & CO

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

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoBoston Scientific Corp — EPIC 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 ↗
    ›Apr 2, 2026device pma116d agoBiotronik, Inc. — Solia CSP S Leads (PMA supplement)

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

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoEndospan , Ltd. — NEXUS Aortic Arch Stent Graft System (PMA)

    Product code: SDZ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Apr 2, 2026device pma116d agoMedtronic, Inc. — Sphere-9 Catheter; Tubing Set; Extension Cable (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $EBRCZ0.2780+48.56%
    $MDT83.21+1.46%
    $IGC0.2670+0.41%
    $BSX44.25+1.54%
    $BDX156.36+2.22%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $GH131.78+2.07%
    $GDNT
    $BDX156.36+2.22%
    $BSX44.25+1.54%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $PMI0.1821-4.66%
    $BSX44.25+1.54%
    $BSX44.25+1.54%