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calendar

2,708 catalysts · 4,728 grant · 3,350 8k filing · 2,718 approval · 2,708 device 510k · 2,000 device recall · 1,906 device pma

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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 510k×from 2025-06-10×clear all
type
  • grant4,728
  • 8k filing3,350
  • approval2,718
  • device 510k2,708
  • device recall2,000
  • device pma1,906
device adverse event
1,000
  • recall686
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 9, 2025

    50
    ›Jun 10, 2025device 510k432d agoDRTECH Corporation — EXTRON 3; EXTRON 5; EXTRON 7 (510k cleared)

    Product code: OWB. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (510k cleared)Fujifilm Holdings Corp

    Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoEndymed Medical, Ltd. — EndyMed PRO MAX (510k cleared)

    Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoNihon Kohden Corporation — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (510k cleared)Nihon Kohden Corporation/ADR

    Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

    Product code: QVP. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoViz. Ai, Inc. — Viz Subdural+, Viz SUBDURAL PLUS (510k cleared)

    Product code: QIH. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoFomed Industries, Inc. — Dental Barrier and Sleeves (510k cleared)Biomed Industries Inc

    Product code: PEM. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k432d agoVitaltec Corporation — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (510k cleared)

    Product code: BTO. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoIntuitive Surgical, Inc. — da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (510k cleared)INTUITIVE SURGICAL INC

    Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoNvision Biomedical Technologies — Impact PEEK Union Nail System (510k cleared)

    Product code: HTY. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoBoston Scientific Corporation — Rezum System (510k cleared)BOSTON SCIENTIFIC CORP

    Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoBonebridge AG — LORRAINE 2.5/3.5mm Distal Humerus System (510k cleared)

    Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoMedtronic, Ireland — Liberant Thrombectomy System (510k cleared)

    Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoWilliam Cook Europe Aps — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (510k cleared)

    Product code: BTR. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoGI Windows, Inc. — Self-Forming Magnet (Flexagon) (510k cleared)

    Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (510k cleared)

    Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoCarl Zeiss Meditec Cataract Technology, Inc. — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (510k cleared)

    Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k431d agoEnpuno Co., Ltd. — Injectable Root Canal Bioceramic Sealer (nRoot SP) (510k cleared)

    Product code: KIF. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoHt Medical D.B.A. Xenix Medical — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (510k cleared)

    Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoNovapproach Spine, LLC — OneLIF™ Interbody Fusion System (510k cleared)

    Product code: OVD. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoBiomérieux — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (510k cleared)Bristol-Myers Squibb Co

    Product code: JWY. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoDavol, Inc. — Bard® Mesh; Bard® Mesh Pre-Shaped (510k cleared)

    Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Fractional CO2 Laser Machine (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoSmith & Nephew, Inc. — TRIGEN Stable Lock Nut & Washer (510k cleared)SMITH & NEPHEW PLC

    Product code: JDS. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoGe Medical Systems Israel — Aurora (510k cleared)

    Product code: KPS. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoEl.En S.P.A. — Deka Bluebeam (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoId-Fish Technology, Inc. — iDart Lyme IgM ImmunoBlot Kit (510k cleared)Fort Technology Inc

    Product code: LSR. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoBiocomposites, Ltd. — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (510k cleared)

    Product code: KWL. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoBeijing Sano Laser S&T Development Co.,Ltd — Q-Switched Nd:YAG Laser (SHE-LSP101-1) (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoJeil Medical Corporation — FIX-L PEEK PLIF and T-PLIF System (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoGm Dos Reis Industria E Comercio — GMReis Fibula Nail System (510k cleared)

    Product code: HSB. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoLg Electronics.Inc — Medical Monitor (32HS710S) (510k cleared)ARROW ELECTRONICS, INC.

    Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoPearl, Inc. — Second Opinion® CS (510k cleared)

    Product code: MYN. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoMedtronic Sofamor Danek, Inc. — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (510k cleared)

    Product code: MQV. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoDmax Co., Ltd. — Multi M Series (510k cleared)

    Product code: EIH. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoOlympus Medical Systems Corporation — Disposable Cytology Brush BC-202D/203D Series (510k cleared)

    Product code: BTG. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoThermo Fisher Scientific (Oxoid Ltd.) — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (510k cleared)THERMO FISHER SCIENTIFIC INC.

    Product code: JTN. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k430d agoFiralis SA — APO-Easy Genotyping kit (510k cleared)Dawn Sea Therapeutics

    Product code: SFC. Advisory committee: Immunology. Type: Direct

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoMicrovention — MV Flow Aspiration Pump (MVFLOWPMP01) (510k cleared)

    Product code: JCX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoIntuitive Surgical, Inc. — Vessel Sealer Curved (480522) (510k cleared)INTUITIVE SURGICAL INC

    Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoContego Medical, Inc. — Excipio LV Prime Thrombectomy Device (510k cleared)

    Product code: QEW. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoMedtronic, Inc. — Medtronic Stedi Extra Support Guidewire (510k cleared)Medtronic plc

    Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoChangsha Anxiang Medical Technology Co., Ltd. — 3 in 1 TENS UNIT (510k cleared)

    Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoLumos Labs, Inc. — Prismira (510k cleared)

    Product code: QFT. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoBrainlab AG — Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (510k cleared)

    Product code: QIH. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoDev4 — Eleganz Fusion Screw System (Fusion Screw System) (510k cleared)

    Product code: HWC. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoAbbott Diagnostics Scarborough, Inc. — BinaxNOW COVID-19 Ag Card (510k cleared)

    Product code: QVF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoMedacta International S.A. — Mfinity Femoral System (510k cleared)Stemedica International S.A.

    Product code: MEH. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

    Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k429d agoFujifilm Corporation — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (510k cleared)Fujifilm Holdings Corp

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
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    $FRTT
    $ISRG394.51-1.68%
    $NHNKF
    $TMO447.81+1.31%
    $ISRG394.51-1.68%
    $MDT91.27+0.76%
    $SNN29.81-1.00%
    $ARW226.78+1.76%
    $BSX51.83+0.27%