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calendar

880 catalysts · 3,359 8k filing · 2,370 grant · 1,843 approval · 1,245 device 510k · 1,000 device adverse event · 880 device pma

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type: device pma×from 2025-11-21×clear all
type
  • 8k filing3,359
  • grant2,370
  • approval1,843
  • device 510k1,245
  • device adverse event1,000
  • device pma880
device recall
718
  • earnings584
  • recall307
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 17, 2025

    6
    ›Nov 21, 2025device pma270d agoLife Technologies Corporation — Oncomine™ Dx Target Test (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 21, 2025device pma270d agoTherakos Development Limited — THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 21, 2025device pma270d agoGE Healthcare — Senographe Pristina 3D (PMA supplement)HCA Healthcare, Inc.

    Supplement type: Normal 180 Day Track. Product code: OTE. Advisory committee: RA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 21, 2025device pma270d agoQiagen — QuantiFERON-TB Gold Plus Test (PMA supplement)QIAGEN N.V.

    Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Nov 21, 2025device pma270d agoPhysio-Control, Inc. — LIFEPAK® 35 monitor/defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 22, 2025device pma269d agoMedtronic, Inc. — Medtronic DBS Therapy for Dystonia (PMA supplement)Medtronic plc

    Supplement type: Panel Track. Product code: SGS. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗

    Week of Nov 24, 2025

    23
    ›Nov 24, 2025device pma267d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma

    Week of Dec 1, 2025

    21
    ›Dec 1, 2025device pma260d agoBoston Scientific Corp — WOLVERINE™ Coronary Cutting Balloon™ (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 1, 2025device pma
    ← prev
    page 1 of 18
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    267d ago
    Hologic, Inc. — Envision Mammography Platform (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma267d agoThe Spectranetics Corp. — Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 24, 2025device pma267d agoExact Sciences Corporation — Cologuard® (PMA supplement)

    Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Nov 24, 2025device pma267d agoOcclutech Holding AG — Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoMicroPort CRM USA, Inc. — ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoEndotronix, Inc. — CorPASS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoMicroPort CRM USA, Inc. — ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoLivaNova USA, Inc. — VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoMicroPort CRM USA, Inc. — ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoMedtronic, Inc. — Micra Transcatheter Pacing Systems (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoInstylla, Inc. — Embrace(TM) Hydrogel Embolic System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoXvivo Perfusion, Inc. — XPS™ with Steen Solution™ Perfusate (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 25, 2025device pma266d agoLumicell, Inc. — Lumicell Direct Visualization System (DVS) (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: SAW. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMedtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMedtronic Neuromodulation — Altaviva™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMed-El Corp. — MED-EL CI System (PMA supplement)

    Supplement type: Panel Track. Product code: MCM. Advisory committee: EN. Decision: APPR

    full page →fda device pma ↗
    ›Nov 26, 2025device pma265d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Ve (PMA supplement)

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

    full page →fda device pma ↗
    ›Nov 28, 2025device pma263d agoCleveland Diagnostics, Inc. — IsoPSA Assay (PMA)Co-Diagnostics, Inc.

    Product code: QRF. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    260d ago
    Abbott — CentriMag™ Circulatory Support System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 2, 2025device pma259d agoMedtronic, Inc. — Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d 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 ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base 24970A (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d 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 ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (PMA)

    Product code: MTF. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 3, 2025device pma258d agoMedtronic, Inc. — Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 4, 2025device pma257d agoBausch and Lomb, Inc., — Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 4, 2025device pma257d agoPhysio-Control, Inc. — LIFEPAK® 35 Defibrillator/monitor (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 4, 2025device pma257d agoLenstec, Inc. — Softec HD; Softec I; Softec HDO; Softec HDM (PMA supplement)

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

    full page →fda device pma ↗
    $QGEN
    $HCA404.68-1.71%
    $BSX51.83+0.27%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $CODX1.51000.00%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%
    $MDT91.27+0.76%