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calendar

1,418 catalysts · 4,728 grant · 3,086 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma

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2026-08-10: 0 catalysts2026-08-11: 57 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 2025-08-21×clear all
type
  • grant4,728
  • 8k filing3,086
  • approval2,606
  • device 510k2,051
  • device recall1,649
  • device pma1,418
device adverse event
1,000
  • earnings583
  • recall551
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 18, 2025

    17
    ›Aug 21, 2025device pma356d agoSaluda Medical Pty, Ltd. — Saluda Medical Evoke SCS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d agoDiaSorin, Inc. — LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d agoW. L. Gore & Associates, Inc. — GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d agoCarl Zeiss Meditec, Inc. — Visumax; VISUMAX 800 (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d 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 ↗
    ›Aug 21, 2025device pma356d agoBaxter Bio Science — Coseal Spray Set (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d agoDiaSorin, Inc. — LIAISON® MUREX Anti-HBc and LIAISON® MUREX Control Anti-HBc (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d 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 21, 2025device pma356d agoDiaSorin, Inc. — LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual and LIAISON® MUREX HBsAg Confirmatory (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 21, 2025device pma356d agoMedtronic, Inc. — Melody Transcatheter Pumonary Valve System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 22, 2025device pma355d agoBoston Scientific — FINELINE® II EZ Sterox (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 22, 2025device pma355d agoBoston Scientific — INGEVITY™ MRI, INGEVITY™ + (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Aug 22, 2025device pma355d agoBiotronik, Inc. — CardioMessenger Smart 4G (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 22, 2025device pma355d agoCerenovus, Inc. — TRUFILL n-BCA Liquid Embolic System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 22, 2025device pma355d agoContego Medical, Inc. — Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 22, 2025device pma355d 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 ↗
    ›Aug 22, 2025device pma355d agoBoston Scientific — ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™ (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗

    Week of Aug 25, 2025

    33
    ›Aug 25, 2025device pma352d 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 ↗
    ›Aug 25, 2025device pma
    ← prev
    page 1 of 29
    next →
    352d ago
    Medtronic Minimed — Guardian Connect system (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoAbbott Vascular, Inc. — XACT Carotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoAlcon Research, Ltd. — AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (PMA supplement)Rubicon Research Ltd

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

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoW. L. Gore & Associates, Inc. — TAG® Thoracic Branch Endoprosthesis (P210032) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoPramand, LLC — CraniSeal­­ Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoMedtronic Minimed, Inc. — MiniMed 670G System (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoAlcon Laboratories, LLC — Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoMedtronic Minimed, Inc. — Simplera Sync Sensor, Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Aug 25, 2025device pma352d agoAlcon Laboratories, Inc. — AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Aug 26, 2025device pma351d agoEndotronix, Inc. — CorPASS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 26, 2025device pma351d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d 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 ↗
    ›Aug 27, 2025device pma350d agoKardium, Inc. — Globe® Pulsed Field System (PMA)Kardigan Inc

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoMerz North America, Inc. — COAPTITE Injectable Implant (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: LNM. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoABBOTT MEDICAL — Avant™ DR CDDRA700Q, CDDRA700T; Gallant™ DR CDDRA500Q, CDDRA500T; Entrant™ DR CDDRA300Q, CDDRA300T; Neutrino™ NxT DR CDD (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoMedtronic, Inc. — Evolut PRO+ System, Evolut FX System, Evolut FX+ System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoHologic, Inc. — ThinPrep Processor and ThinPrep Imaging System (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoABBOTT MEDICAL — IsoFlex™ (1944) (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 27, 2025device pma350d agoABBOTT MEDICAL — Quartet™ 1456Q, 1457Q, 1458Q, 1458QL; Avant™ HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant™ HF CDHFA500B, CDHFA (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoOrganox Limited — OrganOx metra® System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoDiaSorin, Inc. — LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON-TBGold Plus (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoMedtronic, Inc. — SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoDiaSorin, Inc. — LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoZOLL Medical Corporation — AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d 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 ↗
    ›Aug 28, 2025device pma349d 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 ↗
    ›Aug 28, 2025device pma349d agoDiaSorin, Inc. — LIAISON® Murex Anti-HBc and LIAISON® MUREX Control anti-HBc (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoZOLL Medical Corporation — AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 28, 2025device pma349d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe (PMA supplement)

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

    full page →fda device pma ↗
    ›Aug 29, 2025device pma348d agoABBOTT MEDICAL — Infinity™ Deep Brain Stimulation (DBS) IPG (PMA supplement)

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

    full page →fda device pma ↗
    $MDT89.41+2.58%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $BSX50.46+2.33%
    $BDX180.50+0.48%
    $TATT
    $MDT89.41+2.58%
    $MDT89.41+2.58%
    $MDT89.41+2.58%