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calendar

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 Jan 12, 2026

    7
    ›Jan 16, 2026device pma191d 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 pma191d 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 pma191d 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 pma191d 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 pma191d 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 pma191d 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 pma191d 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

    22
    ›Jan 20, 2026device pma187d 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

    Week of Jan 26, 2026

    21
    ›Jan 26, 2026device pma181d agoDiaSorin, Inc. — LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NCD. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    ›Jan 27, 2026device pma
    ← prev
    page 30 of 40
    next →
    187d 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 pma187d 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 pma187d 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 pma186d 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 pma186d 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 pma185d 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 pma185d 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 pma185d 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 pma185d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 pma184d 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 ↗
    ›Jan 23, 2026device pma184d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026device pma184d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    180d ago
    Boston 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 ↗
    ›Jan 27, 2026device pma180d agoMedtronic Vascular — Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoUromedica, Inc. — ProACT™ Adjustable Continence Therapy for Men (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoAgilent Technologies Singapore (International) Pte , Ltd. — HercepTest™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoETHICON, Inc. — ETHIZIA™ Hemostatic Patch (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoContego Medical, Inc. — Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoFerrosan Meidcal Devices A/S — SURGIFOAM Absorbable Gelatin Sponge, USP (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Attesta DR MRl IPG; Attesta DR MRl IPG; (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoWomed Sas — Womed Leaf (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoInsightec — Exablate Model 4000 System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 28, 2026device pma179d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jan 29, 2026device pma178d agoQ-Med AB — Restylane®-L 1 mL; Restylane® Lyft™ with Lidocaine 1 mL; Restylane® Eyelight™ 0.5 mL (PMA supplement)Sustained Therapeutics Inc

    Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Jan 29, 2026device pma178d agoVascutek, Ltd. — Thoraflex™ Hybrid (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 29, 2026device pma178d agoAutoGenomics, Inc. — AvertD™ and AvertD™ Buccal Sample Collection Kit (PMA supplement)NEOGENOMICS INC

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

    full page →fda device pma ↗
    ›Jan 29, 2026device pma178d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 29, 2026device pma178d agoHighridge Medical, LLC — activL Artificial Disc (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 30, 2026device pma177d 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 ↗
    ›Jan 30, 2026device pma177d agoBoston Scientific Corp — Eluvia Drug-Eluting Vascular Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 30, 2026device pma177d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $QGEN
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $EW91.33-2.47%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $NEO14.73+3.44%
    $MDT83.21+1.46%