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calendar

2,700 catalysts · 4,728 grant · 3,603 8k filing · 2,716 approval · 2,700 device 510k · 2,000 device recall · 1,899 device pma

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 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: 1 catalyst2026-10-01: 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 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2025-06-11×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,716
  • device 510k2,700
  • device recall2,000
  • device pma1,899
device adverse event
1,000
  • recall686
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 9, 2025

    48
    ›Jun 11, 2025device 510k446d 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 510k446d 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 510k446d 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 510k446d 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 510k446d agoMedtronic, Ireland — Liberant Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k446d 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 510k446d 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 510k446d 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 510k446d 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 510k446d 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 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d agoGe Medical Systems Israel — Aurora (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d 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 510k445d agoPearl, Inc. — Second Opinion® CS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k445d 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 510k445d agoDmax Co., Ltd. — Multi M Series (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k445d 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 510k445d 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 510k445d 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 510k444d 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 510k444d 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 510k444d 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 510k444d 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 510k444d 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 510k444d agoLumos Labs, Inc. — Prismira (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k444d 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 510k444d 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 510k444d 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 510k444d 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 510k444d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k444d 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 ↗
    ›Jun 13, 2025device 510k444d agoFresenius Medical Care Renal Therapies Group, LLC — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k444d agoInomed Medizintechnik GmbH — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k444d agoRivanna Medical, Inc. — Accuro® 3S Needle Guide Kit (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jun 15, 2025device 510k442d agoBestway Plastic and Metal Products , Ltd. — IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 15, 2025device 510k442d agoWithings — Withings ECG App (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 15, 2025device 510k442d agoBioptimal International Pte. , Ltd. — Bioptimal Bipolar Pacing Catheter (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 16, 2025

    2
    ›Jun 16, 2025device 510k441d agoExpanding Innovations, Inc. — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k
    ← prev
    page 1 of 54
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    441d ago
    Siemens Healthcare GmbH — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (510k cleared)

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

    full page →fda device 510k ↗
    $ISRG372.60+1.51%
    $ARW226.78+1.76%
    $TMO447.81+1.31%
    $ISRG372.60+1.51%
    $FRTT
    $MDT91.23+1.40%
    $SNN28.97-0.55%
    $BSX46.84+0.36%
    $FMS23.10-0.73%
    $VANI1.6000+18.52%