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calendar

633 catalysts · 3,045 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma

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type: device pma×from 2026-01-02×clear all
type
  • 8k filing3,045
  • grant2,098
  • approval1,170
  • device adverse event1,000
  • device 510k885
  • device pma633
earnings
579
  • device recall415
  • recall220
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 29, 2025

    4
    ›Jan 2, 2026device pma221d 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 pma221d 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 pma221d 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 pma221d 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 ↗

    Week of Jan 5, 2026

    42
    ›Jan 5, 2026device pma218d 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

    Week of Jan 12, 2026

    4
    ›Jan 12, 2026device pma211d 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 1 of 13
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    218d 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 pma218d agoStereotaxis, Inc. — MAGiC Ablation Catheter (PMA)Stereotaxis, Inc.

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

    full page →fda device pma ↗
    ›Jan 5, 2026device pma218d 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 pma218d 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 pma218d 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 pma217d 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 pma217d 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 pma217d 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 pma217d 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 pma217d 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 pma217d 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 pma217d 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 pma216d 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 pma216d 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 pma216d 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 pma216d 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 pma216d 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 pma216d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 ↗
    ›Jan 8, 2026device pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma214d 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 pma214d 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 pma214d 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 pma214d 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 ↗
    211d 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 pma211d 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 pma211d 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 ↗
    $BSX50.46+2.33%
    $JNJ261.81+0.99%
    $MDT89.41+2.58%
    $LCTC
    $NVCR20.05+28.74%
    $STXS1.8800+5.62%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $GDNT
    $TATT
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $JNJ261.81+0.99%
    $JNJ261.81+0.99%