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calendar

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 Dec 22, 2025

    7
    ›Dec 23, 2025device pma215d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d 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 ↗
    ›Dec 23, 2025device pma215d agoVantive US Healthcare, LLC — Gambro Prismaflex TPE 2000 Set (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoBiosense Webster, Inc. — TRUPULSE™ Generator (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoBiosense Webster, Inc. — nGEN™ Pump (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoABBOTT MEDICAL — Proclaim Dorsal Root Ganglion (DRG) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma215d agoEndologix, LLC — DETOUR System (PMA supplement)

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

    full page →fda device pma ↗

    Week of Dec 29, 2025

    14
    ›Dec 29, 2025device pma209d agoGuardant Health, Inc. — Guardant360 CDx (PMA supplement)Guardant Health, Inc.

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

    full page →fda device pma ↗
    ›Dec 30, 2025device pma

    Week of Jan 5, 2026

    29
    ›Jan 5, 2026device pma202d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 5, 2026device pma
    ← prev
    page 28 of 40
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    208d ago
    ZOLL Medical Corporation — OneStep CPR Complete Electrode (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoRoche Molecular System, Inc. — cobas® EZH2 Mutation Test (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoRoche Molecular Systems, Inc. — cobas® KRAS Mutation Test (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoSmith & Nephew, Inc. — Ascension MCP (PMA supplement)SMITH & NEPHEW PLC

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoNeurolief , Ltd. — Proliv™Rx System (PMA)

    Product code: JXK. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoRoche — cobas® EGFR Mutation Test, v2.0 (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 31, 2025device pma207d agoRoche Molecular Systems, Inc. — cobsa® BRAF V600 Mutation Test (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 2, 2026device pma205d agoMentor Corp. — MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 2, 2026device pma205d agoBoston Scientific Corporation — Bulkamid Urethral Bulking System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 2, 2026device pma205d agoBiosense Webster, Inc. — VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 2, 2026device pma205d agoMentor Worldwide, LLC — MENTOR™ MemoryShape™ Breast Implants (PMA supplement)

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

    full page →fda device pma ↗
    202d ago
    Boston Scientific Corporation — ORBERA INTRAGASTRIC BALLOON (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 5, 2026device pma202d agoStereotaxis, Inc. — MAGiC Ablation Catheter (PMA)Stereotaxis, Inc.

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

    full page →fda device pma ↗
    ›Jan 5, 2026device pma202d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 5, 2026device pma202d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 5, 2026device pma202d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Jan 6, 2026device pma201d agoKardium, Inc. — 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 ↗
    ›Jan 6, 2026device pma201d agoVentana Medical Systems, Inc. (Roche Tissue Diagnostics) — VENTANA anti-MSH6 (SP93) Antibody (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 6, 2026device pma201d agoVentana Medical Systems — VENTANA anti-MSH6 (SP93) Antibody (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 6, 2026device pma201d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 6, 2026device pma201d agoSaluda Medical Pty, Ltd. — Saluda Medical Evoke SCS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 6, 2026device pma201d agoCordis US Corporation — EXOSEAL® Vascular Closure Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 6, 2026device pma201d agoExact Sciences Corporation — Stool DNA (sDNA) Test, Cologuard Plus™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 7, 2026device pma200d agoVeryan Medical, Ltd. — BioMimics 3D® Vascular Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 7, 2026device pma200d 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 ↗
    ›Jan 7, 2026device pma200d 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 7, 2026device pma200d agoLimFlow, Inc. — LimFlow System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 7, 2026device pma200d 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 7, 2026device pma200d agoCooperVision, Inc. — comfilcon A Soft (Hydrophilic) Contact Lenses for daily wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead 3830 (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoBoston Scientific — Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131; PROPONENT Models: (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 ↗
    ›Jan 8, 2026device pma199d agoCordis US Corporation — EXOSEAL® Vascular Closure Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoBoston Scientific Corp — Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models: L100, L101, (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 ↗
    ›Jan 8, 2026device pma199d agoAlcon Research, LLC — UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoBoston Scientific Corporation — Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 (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 ↗
    ›Jan 8, 2026device pma199d agoABBOTT MEDICAL — TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex 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 agoBoston Scientific — NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152, D153; INOG (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 ↗
    ›Jan 8, 2026device pma199d agoCordis US Corporation — S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 8, 2026device pma199d agoGuidant Corp. — Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models U225, U226 (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    $GH131.78+2.07%
    $MDT83.21+1.46%
    $SNN30.25+5.29%
    $BSX44.25+1.54%
    $LCTC
    $STXS1.8800+5.62%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $NVCR20.05+28.74%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $GDNT
    $BSX44.25+1.54%