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calendar

329 catalysts · 3,350 8k filing · 1,425 grant · 1,000 device adverse event · 662 approval · 582 earnings · 526 device 510k

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 0 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 2026-02-19×clear all
type
  • 8k filing3,350
  • grant1,425
  • device adverse event1,000
  • approval662
  • earnings582
  • device 510k526
device pma
329
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Feb 16, 2026

    27
    ›Feb 19, 2026device pma178d agoABBOTT MEDICAL — Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoAlcon Laboratories, LLC — Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic (PMA supplement)Alcon Laboratories Inc

    Supplement type: Real-Time Process. Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoABBOTT MEDICAL — Quartet; QuickFlex Micro (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d 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 ↗
    ›Feb 19, 2026device pma178d agoABBOTT MEDICAL — Durata, Optisure (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoMedtronic Neuromodulation — Master Restore, Itrel, Synerg, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoABBOTT MEDICAL — Tendril STS; OptiSense; UltiPace (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoBiomet Microfixation, Inc. — Total Temporomandibular Joint Replacement System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoABBOTT MEDICAL — IsoFlex (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 19, 2026device pma178d agoEdwards Lifesciences, LLC — SAPIEN M3 Transcatheter Mitral Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoBiotronik, Inc. — Orsiro Mission Sirolimus Eluting Coronary Stent System, Synsiro Pro Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoMedtronic Vascular, Inc. — Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoAllurion Technologies, Inc. — Allurion™ Gastric Balloon System (PMA)ALLURION TECHNOLOGIES, INC.

    Product code: LTI. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoInspireMD, Ltd. — CGuard™ Prime Carotid Stent System (PMA supplement)InspireMD, Inc.

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoBoston Scientific — ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — PIPELINE EMBOLIZATION DEVICE (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoBoston Scientific Corporation — EMBLEM S-ICD Electrode (Lead) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoW. L. Gore & Associates, Inc. — GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoMedtronic, Inc. — Myocardial Pacing Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoSyncardia Systems, LLC — SynCardia Total Artificial Heart (STAH) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoNeuroPace, Inc. — NeuroPace® RNS® System (PMA supplement)NeuroPace Inc

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 20, 2026device pma177d agoMedtronic Vascular, Inc. — EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 22, 2026device pma175d agoBiotronik, Inc. — Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

    full page →fda device pma ↗

    Week of Feb 23, 2026

    23
    ›Feb 23, 2026device pma174d agoABBOTT MEDICAL — Aveir DR Delivery Catheter (LSCD201) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 23, 2026device pma
    ← prev
    page 1 of 7
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    174d ago
    Abbott Laboratories — ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (PMA supplement)ABBOTT LABORATORIES

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

    full page →fda device pma ↗
    ›Feb 23, 2026device pma174d 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 pma174d 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 pma174d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma173d 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 pma172d 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 pma172d 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 pma172d 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 pma172d 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 pma172d 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 pma172d 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 pma172d 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 ↗
    $MDT91.27+0.76%
    $NSPR0.7300+0.10%
    $BSX51.83+0.27%
    $NPCE15.85-0.88%
    $BSX51.83+0.27%
    $EW91.33-2.47%
    $ALUR0.8500-6.59%
    $INSP42.44+0.38%
    $ABT111.25-0.02%
    $BSX51.83+0.27%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $BSX51.83+0.27%
    $NVCR20.05+28.74%
    $BSX51.83+0.27%
    $BSX51.83+0.27%
    $IART18.34+0.55%
    $NVCR20.05+28.74%