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calendar

1,125 catalysts · 3,315 8k filing · 2,402 grant · 2,318 approval · 1,648 device 510k · 1,198 device recall · 1,125 device pma

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type: device pma×from 2025-10-06×clear all
type
  • 8k filing3,315
  • grant2,402
  • approval2,318
  • device 510k1,648
  • device recall1,198
  • device pma1,125
device adverse event
1,000
  • earnings584
  • recall465
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 6, 2025

    42
    ›Oct 6, 2025device pma313d agoOphtec BV — Capsular Tension Ring (275,276); RingJect (375,376) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 6, 2025device pma313d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 6, 2025device pma313d agoEndotronix, Inc. — CorPASS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoHologic, Inc. — Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoExact Sciences Corporation — Cologuard® (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoGen-Probe Incorporated — Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoAtriCure, Inc. — EPi-Sense Guided Coagulation System (PMA supplement)AtriCure, Inc.

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 7, 2025device pma312d agoGen-Probe Incorporated — Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 8, 2025device pma311d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 8, 2025device pma311d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 8, 2025device pma311d agoRxsight, Inc. — Light Adjustable Lens and Light Delivery Device (PMA supplement)RxSight, Inc.

    Supplement type: Real-Time Process. Product code: PZK. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Oct 8, 2025device pma311d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 8, 2025device pma311d 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 ↗
    ›Oct 8, 2025device pma311d agoTorax Medical — LINX Reflux Management System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoETHICON, Inc. — SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoETHICON, Inc. — GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoEndologix, LLC — DETOUR System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoMedtronic Cardiac Rhythm Disease Management — MEDTRONIC SELECTSECURE LEAD MODEL 3830 (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d 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 ↗
    ›Oct 9, 2025device pma310d agoMedtronic Minimed, Inc. — Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoIntrinsic Therapeutics — Barricaid® Annular Closure Device (PMA supplement)Insignis Therapeutics Inc

    Supplement type: Normal 180 Day Track. Product code: QES. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoRayner Intraocular Lenses , Ltd. — RayOne EMV Toric (PMA supplement)

    Supplement type: Panel Track. Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoMedtronic Minimed — Guardian Connect System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 9, 2025device pma310d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoMedtronic, Inc. — DiamondTemp Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoMerz North America, Inc. — Belotero Balance (+) Lidocaine Dermal Filler (PMA supplement)Sustained Therapeutics Inc

    Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoBolton Medical, Inc. — RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoCentinel Spine, LLC — prodisc C SK and prodisc C Vivo (PMA supplement)

    Supplement type: Panel Track. Product code: MJO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL Murex Anti-HBc and LIAISON® XL MUREX Control anti-HBc (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoBiotronik, Inc. — Orsiro Mission Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (PMA supplement)

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

    full page →fda device pma ↗

    Week of Oct 13, 2025

    8
    ›Oct 14, 2025device pma305d agoShockwave Medical, Inc. — Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 14, 2025device pma
    ← prev
    page 1 of 23
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    305d ago
    Physio-Control, Inc. — LIFEPAK 1000 defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 14, 2025device pma305d agoAdvanced Bionics — HiResolution™ Bionic Ear System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma304d agoABBOTT MEDICAL — FlexNav Delivery System; Navitor Transcatheter Aortic Valves (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma304d agoABBOTT MEDICAL — Masters Series Mechanical Heart Valve (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma304d agoAnika Therapeutics, Inc. — Ophthalin; Nuvisc; Anikavisc (PMA supplement)Anika Therapeutics, Inc.

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma304d agoLife Technologies Corporation — Oncomine Dx Express Test (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 15, 2025device pma304d agoW. L. Gore & Associates, Inc. — GORE® TAG® Conformable Thoracic Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    $NVCR20.05+28.74%
    $ANIK
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $RXST
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $ATRC
    $EW91.33-2.47%
    $MDT90.58-0.20%