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calendar

616 catalysts · 3,062 8k filing · 2,093 grant · 1,139 approval · 1,000 device adverse event · 865 device 510k · 616 device pma

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2026-08-10: 0 catalysts2026-08-11: 33 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 2026-01-07×clear all
type
  • 8k filing3,062
  • grant2,093
  • approval1,139
  • device adverse event1,000
  • device 510k865
  • device pma616
earnings
583
  • device recall394
  • recall220
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 5, 2026

    29
    ›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 ↗

    Week of Jan 12, 2026

    21
    ›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
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    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 ↗
    ›Jan 12, 2026device pma211d agoAbbott Vascular-Cardiac Therapies — Omnilink Elite Vascular Balloon-Expandable Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d 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 13, 2026device pma210d 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 13, 2026device pma210d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d agoABBOTT MEDICAL — Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d agoABBOTT MEDICAL — Eterna SCS and Proclaim SCS Systems (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d agoMerz North America, Inc. — COAPTITE (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma210d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma209d agoTeoxane S.A. — RHA® Redensity dermal filler (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Jan 14, 2026device pma209d agoCardiovascular Systems, Inc. — Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma209d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: SDL. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Jan 14, 2026device pma209d 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 14, 2026device pma209d 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 ↗
    ›Jan 14, 2026device pma209d agoAdvanced Medical Solutions Limited — LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma209d 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 ↗
    $BSX50.46+2.33%
    $TATT
    $BSX50.46+2.33%
    $GDNT
    $BSX50.46+2.33%
    $NVCR20.05+28.74%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $JNJ261.81+0.99%
    $JNJ261.81+0.99%
    $JNJ261.81+0.99%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $BSX50.46+2.33%