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calendar

573 catalysts · 3,288 8k filing · 2,079 grant · 1,097 approval · 1,000 device adverse event · 800 device 510k · 584 earnings

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 118 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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 2026-01-14×clear all
type
  • 8k filing3,288
  • grant2,079
  • approval1,097
  • device adverse event1,000
  • device 510k800
  • earnings584
device pma
573
  • device recall291
  • recall215
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 12, 2026

    30
    ›Jan 14, 2026device pma212d 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 pma212d 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 pma212d 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 pma212d 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 pma212d 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 pma212d 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 pma212d 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 pma212d 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 pma212d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma211d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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 pma210d 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

    20
    ›Jan 20, 2026device pma206d 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
    next →
    206d 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 pma206d 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 pma206d 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 pma205d 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 pma205d 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 ↗
    ›Jan 22, 2026device pma204d agoETHICON, Inc. — ETHIZIA™ Hemostatic Patch (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma204d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma204d agoBoston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma204d agoEndologix, LLC — DETOUR System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic Vascular, Inc. — Protégé RX Carotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMed-El Corp. — MED-EL Cochlear Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoQiagen — QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test (PMA supplement)QIAGEN N.V.

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic, Inc. — Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic, Inc. — Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoMedtronic Minimed — MiniMed Go app; Simplera sensor (PMA supplement)

    Supplement type: Real-Time Process. Product code: MDS. Advisory committee: CH. Decision: APPR

    full page →fda device pma ↗
    ›Jan 23, 2026device pma203d agoAdvanced Bionics — HiResolution Bionic Ear System (PMA supplement)

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

    full page →fda device pma ↗
    $MDT90.58-0.20%
    $GH131.78+2.07%
    $BSX51.39-0.07%
    $BSX51.39-0.07%
    $MDT90.58-0.20%
    $BSX51.39-0.07%
    $BSX51.39-0.07%
    $QGEN
    $MDT90.58-0.20%
    $BSX51.39-0.07%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%