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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 Feb 23, 2026

    50
    ›Feb 23, 2026device pma154d agoPhysio-Control, Inc. — LIFEPAK® 35 monitor/defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 23, 2026device pma154d agoMedtronic, Inc. — Miera AV TPS; Miera TPS (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 23, 2026device pma154d agoInspire Medical Systems — Model 3028 Connector Block Laser Weld Inspection Update (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma153d 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 ↗
    ›Feb 24, 2026device pma153d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Programming Systems A510, A511, A520, A521) (PMA supplement)

    Supplement type: Real-Time Process. Product code: EZW. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 24, 2026device pma153d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Programming Systems A510, A511, A520, A521) (PMA supplement)

    Supplement type: Real-Time Process. Product code: QON. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 24, 2026device pma153d agoMedtronic Sofamor Danek USA, Inc. — INFUSE Bone Graft (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma153d 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 ↗
    ›Feb 24, 2026device pma153d agoMedtronic Sofamor Danek USA, Inc. — INFUSE Bone Graft/Medtronic Interbody Fusion Device (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Feb 24, 2026device pma153d agoMedtronic, Inc. — INFUSE Bone Graft (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NPZ. Advisory committee: DE. Decision: OK30

    full page →fda device pma ↗
    ›Feb 24, 2026device pma153d 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 ↗
    ›Feb 24, 2026device pma153d 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 ↗
    ›Feb 24, 2026device pma153d 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 ↗
    ›Feb 24, 2026device pma153d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Amulet) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma152d agoNovocure, GmbH — Optune Gio® (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma152d 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 ↗
    ›Feb 25, 2026device pma152d 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 ↗
    ›Feb 25, 2026device pma152d agoABBOTT MEDICAL — TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma152d agoIntegra Lifesciences Corp. — INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma152d agoABBOTT MEDICAL — MitraClip™ G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 25, 2026device pma152d 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 ↗
    ›Feb 25, 2026device pma152d agoBoston Scientific Corp — AMS 800™ Artificial Urinary Sphincter (AUS) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoMedtronic, Inc. — CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Delivery Catheter System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoCardiovascular Systems, Inc. — Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoScibase AB — Nevisense (PMA supplement)

    Supplement type: Real-Time Process. Product code: ONV. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoIntera Oncology — lntera 3000 Hepatic Artery Infusion Pump (PMA supplement)

    Supplement type: Real-Time Process. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoAlcon Laboratories, Inc. — Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoMicroTransponder, Inc. — Vivistim® Paired VNS System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QPY. Advisory committee: PM. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d 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 ↗
    ›Feb 26, 2026device pma151d agoKARL STORZ Endoscopy-America, Inc. — Photodynamic Diagnostic D-Light C (PDD) System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: OAY. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma151d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA)

    Product code: MJO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoIntegra LifeSciences Corporation — DuraSeal Exact Spine Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

    Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoMedtronic, Inc. — Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoTeleflex Medical, LLC — MANTA™ Vascular Closure Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d 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 ↗
    ›Feb 27, 2026device pma150d agoIntegra LifeSciences Corporation — DuraSeal Dural Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

    Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoRoche Diagnostics Corp. — Elecsys total PSA assay (PMA supplement)CS DIAGNOSTICS CORP.

    Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d 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 ↗
    ›Feb 27, 2026device pma150d agoRoche Diagnostics Corp. — Elecsys free PSA assay (PMA supplement)CS DIAGNOSTICS CORP.

    Supplement type: 30-Day Notice. Product code: LTJ. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoABBOTT MEDICAL — Next Gen Patient System – CM1200 CardioMEMS HERO Device (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MOM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d 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 ↗
    ›Feb 27, 2026device pma150d agoMedtronic Vascular — Endurant™, Endurant™ II/lls Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoMedtronic Vascular — Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d agoSymatese — Evolysse™ Smooth; Evolysse™ Form (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma150d 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 ↗
    ›Feb 27, 2026device pma150d 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 ↗
    ›Feb 27, 2026device pma150d 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 ↗
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