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calendar

539 catalysts · 3,045 8k filing · 2,046 grant · 1,007 approval · 1,000 device adverse event · 732 device 510k · 579 earnings

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2026-08-10: 0 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device pma×from 2026-01-21×clear all
type
  • 8k filing3,045
  • grant2,046
  • approval1,007
  • device adverse event1,000
  • device 510k732
  • earnings579
device pma
539
  • device recall255
  • recall204
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 19, 2026

    18
    ›Jan 21, 2026device pma202d 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 pma202d 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 pma201d 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 pma201d 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 pma201d 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 pma201d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 pma200d 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 ↗

    Week of Jan 26, 2026

    24
    ›Jan 26, 2026device pma197d 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

    Week of Feb 2, 2026

    8
    ›Feb 2, 2026device pma190d agoPhilips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Feb 2, 2026device pma
    ← prev
    page 1 of 11
    next →
    196d 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 pma196d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma195d 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 pma194d 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 pma194d 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 pma194d 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 pma194d 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 pma194d 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 pma193d 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 pma193d 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 pma193d 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 ↗
    ›Jan 30, 2026device pma193d agoInspire Medical Systems — QMR Battery Separator Supplier (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›Jan 30, 2026device pma193d agoBalt USA, LLC — SQUID Liquid Embolic Agent (LEA) (PMA)Bayer USA LLC

    Product code: SGU. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jan 30, 2026device pma193d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)DFB Soria LLC

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

    full page →fda device pma ↗
    190d ago
    CooperVision, Inc. — Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 2, 2026device pma190d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Feb 2, 2026device pma190d agoPhilips Medical Systems — HeartStart FRx Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma189d agoGen-Probe Incorporated — Aptima HPV 16 18/45 Genotype Assay (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma189d agoBiotronik, Inc. — PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma189d agoABBOTT MEDICAL — TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 3, 2026device pma189d agoGen-Probe Incorporated — APTIMA HPV ASSAY (PMA supplement)

    Supplement type: Panel Track. Product code: OYB. Advisory committee: MI. Decision: APPR

    full page →fda device pma ↗
    $MDT89.41+2.58%
    $QGEN
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $MMSI89.75+0.80%
    $EW91.33-2.47%
    $MDT89.41+2.58%
    $NEO14.73+3.44%
    $MDT89.41+2.58%
    $BSX50.46+2.33%
    $BSX50.46+2.33%
    $MDT89.41+2.58%
    $EW91.33-2.47%
    $INSP42.44+0.38%