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calendar

587 catalysts · 3,350 8k filing · 2,088 grant · 1,110 approval · 1,000 device adverse event · 820 device 510k · 587 device pma

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type: device pma×from 2026-01-12×clear all
type
  • 8k filing3,350
  • grant2,088
  • approval1,110
  • device adverse event1,000
  • device 510k820
  • device pma587
earnings
584
  • device recall307
  • recall215
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 12, 2026

    44
    ›Jan 12, 2026device pma216d 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 pma216d agoFarapulse, 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 pma216d 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 pma216d 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 pma216d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma215d 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 pma214d 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 pma214d 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 pma214d 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 pma214d 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 pma214d 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 pma214d 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 pma214d 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 ↗
    ›Jan 14, 2026device pma214d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 14, 2026device pma214d 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 15, 2026device pma213d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoGuardant Health, Inc. — Guardant360 CDx (PMA supplement)Guardant Health, Inc.

    Supplement type: Panel Track. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoSt Jude Medical — Livewire™ TC XLS™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoCentinel Spine, LLC — prodisc® C (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoABBOTT MEDICAL — FlexAbility™ and FlexAbility™ Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoMicroPort CRM USA, Inc. — VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoETHICON, Inc. — GYNECARE INTERCEED™ Absorbable Adhesion Barrier (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoABBOTT MEDICAL — TactiFlex™ Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoIrvine Biomedical,Inc.(Ibi) — Safire™ TX Bi-directional and Therapy™ Dual-8™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 15, 2026device pma213d agoSt Jude Medical — TactiCath™ Sensor Enabled™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoSetPoint Medical — SetPoint System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoMedtronic, Inc. — Harmony™ Transcatheter Pulmonic Valve System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoBiomet Manufacturing Corp — Oxford Partial Knee System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NRA. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoZimmer, Inc. — NexGen® LPS-Flex / LPS Mobile Bearing Knee System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoTorax Medical — LINX Reflux Management System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Jan 16, 2026device pma212d agoTorax Medical — LINX™ Reflux Management System (PMA supplement)

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

    full page →fda device pma ↗

    Week of Jan 19, 2026

    6
    ›Jan 20, 2026device pma208d agoRayner Intraocular Lenses , Ltd. — Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 20, 2026device pma
    ← prev
    page 1 of 12
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    208d ago
    Medtronic Neuromodulation — InterStim TM Therapy System, Verify ™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 20, 2026device pma208d agoMedtronic, Inc. — SynchroMed ™ Infusion System, Ascenda ® Intrathecal Catheters (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 20, 2026device pma208d agoMedtronic Neuromodulation — InterStim TM Therapy System, Verify ™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 21, 2026device pma207d agoTusker Medical, Inc. — Tula Tube Delivery System (TDS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 21, 2026device pma207d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    $JNJ260.35-0.66%
    $MDT91.27+0.76%
    $JNJ260.35-0.66%
    $BSX51.83+0.27%
    $GH131.78+2.07%
    $BSX51.83+0.27%
    $JNJ260.35-0.66%
    $BSX51.83+0.27%
    $BSX51.83+0.27%
    $BSX51.83+0.27%
    $MDT91.27+0.76%