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calendar

941 catalysts · 3,382 8k filing · 2,401 grant · 2,059 approval · 1,416 device 510k · 1,000 device adverse event · 949 device recall

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type: device pma×from 2025-10-30×clear all
type
  • 8k filing3,382
  • grant2,401
  • approval2,059
  • device 510k1,416
  • device adverse event1,000
  • device recall949
device pma
941
  • earnings584
  • recall364
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 27, 2025

    11
    ›Oct 30, 2025device pma292d agoMedtronic, Inc. — SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d agoSiemens Medical Solutions Diagnostics Limited — IMMULITE 2000 Free PSA (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d 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 ↗
    ›Oct 30, 2025device pma292d agoMedtronic, Inc. — Avalus Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

    Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d agoMedtronic, Inc. — OmniaSecure™ MRI SureScan™ Lead Model 3930M (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d agoSiemens Healthcare Diagnostics, Inc. — IMMULITE 2000 AFP (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d agoABBOTT MEDICAL — Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra and Epic™ Max Stented Tissue Valve (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 30, 2025device pma292d agoSiemens Healthcare Diagnostics, Inc. — IMMULITE 2000 PSA (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 31, 2025device pma291d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Nov 2, 2025device pma289d agoMicroVention, Inc. — Flow Re-Direction Endoluminal Device (FRED®) System (PMA supplement)MICROVISION, INC.

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

    full page →fda device pma ↗

    Week of Nov 3, 2025

    21
    ›Nov 3, 2025device pma288d agoBeckman Coulter, Inc. — Access AFP (on DxI 9000 Analyzer) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LOK. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Nov 4, 2025device pma

    Week of Nov 10, 2025

    12
    ›Nov 10, 2025device pma281d agoMedtronic, Inc. — Hancock II Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma

    Week of Nov 17, 2025

    6
    ›Nov 18, 2025device pma273d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 18, 2025device pma
    ← prev
    page 1 of 19
    next →
    287d ago
    Q-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

    Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Nov 4, 2025device pma287d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma287d agoMedtronic Neuromodulation — nterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma287d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma287d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (LVAS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma287d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 4, 2025device pma287d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 5, 2025device pma286d agoPromega Corporation — OncoMate® MSI Dx Analysis System (PMA)

    Product code: SFL. Advisory committee: MG. Decision: APPR

    full page →fda device pma ↗
    ›Nov 6, 2025device pma285d agoNyxoah S.A. — Genio® System 2.1 (PMA supplement)Nyxoah SA

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma285d agoStryker Leibinger GmbH & Co KG — Adherus AutoSpray Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma285d agoPhysio-Control, Inc. — LIFEPAK® CR2 Automated External Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 6, 2025device pma285d agoBoston Scientific Corp — WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoABBOTT MEDICAL — Dorsal Root Ganglion (DRG) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoABBOTT MEDICAL — Spinal Cord Stimulation (SCS) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoPramand, LLC — SpineSeal™ Spine Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoMedtronic Vascular, Inc. — EverFlex self-expanding Peripheral Stent System (EverFlex) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoIntersect Ent. — Propel Contour Sinus Implant (PMA supplement)

    Supplement type: Real-Time Process. Product code: OWO. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoABBOTT MEDICAL — Deep Brain Stimulation (DBS) Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 7, 2025device pma284d agoMedtronic Vascular, Inc. — Protégé GPS self-expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 8, 2025device pma283d agoSaluda Medical Pty, Ltd. — Saluda Medical Evoke® SCS System (PMA supplement)

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

    full page →fda device pma ↗
    281d ago
    ABBOTT MEDICAL — CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma281d agoMedtronic, Inc. — Freestyle Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma281d agoMedtronic, Inc. — Mosaic Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 10, 2025device pma281d agoMedtronic, Inc. — Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 12, 2025device pma279d agoGraphic Controls D.B.A. Vermed — HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma278d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma278d agoMedtronic, Inc. — SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Nov 13, 2025device pma278d agoBaxter Healthcare Corp — Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (PMA supplement)Baxter Healthcare Corp

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

    full page →fda device pma ↗
    ›Nov 13, 2025device pma278d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 14, 2025device pma277d agoAtriCure, Inc. — EPi-Sense ST Coagulation System (PMA supplement)AtriCure, Inc.

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

    full page →fda device pma ↗
    ›Nov 14, 2025device pma277d agoSTAAR Surgical Company — VISIAN ICL (IMPLANTABLE COLLAMER LENS) (PMA supplement)STAAR SURGICAL CO

    Supplement type: Normal 180 Day Track. Product code: MTA. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    273d ago
    Philips Image Guided Therapy Corporation — Duo Venous Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 18, 2025device pma273d agoMentor Worldwide, LLC — MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants (PMA supplement)Revalesio Corp

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

    full page →fda device pma ↗
    ›Nov 19, 2025device pma272d agoLife Technologies Corporation — Oncomine Dx Target Test (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 19, 2025device pma272d agoEdwards Lifesciences, LLC — EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Nov 19, 2025device pma272d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

    full page →fda device pma ↗
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $EW91.33-2.47%
    $MVIS2.1400-4.25%
    $GH131.78+2.07%
    $BSX51.43-0.77%
    $NYXH
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $MDT90.60-0.73%
    $ATRC
    $STAA24.09-7.98%
    $EW91.33-2.47%