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calendar

3,640 catalysts · 4,728 grant · 3,640 device 510k · 3,350 8k filing · 2,970 approval · 2,000 device pma · 2,000 device recall

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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 2025-02-28×clear all
type
  • grant4,728
  • device 510k3,640
  • 8k filing3,350
  • approval2,970
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall894
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Feb 24, 2025

    20
    ›Feb 28, 2025device 510k534d agoRb Health (Us), LLC — Durex Polyisoprene Condom (510k cleared)Bausch Health US LLC

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-02, DS-01) (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoBasis Medical — Seclusion Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoQingdao Kingon Medical Science and Technology Co., Ltd. — Portable Oxygen Concentrator (P2-TOC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoPhenox Limited — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (510k cleared)

    Product code: POL. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoShandon Diagnostics Limited — E1000 Dx Digital Pathology Solution (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoBaxter Healthcare Corporation — Intravascular Extension Sets and Accessories (510k cleared)Baxter Healthcare Corp

    Product code: FPA. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoQIAGEN GmbH — QIAstat-Dx GI Panel 2 Mini B (510k cleared)

    Product code: PCH. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoHeroic Faith International , Ltd. — Airmod (510k cleared)TH International Ltd

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoW&H Dentalwerk Bürmoos GmbH — Synea Fusion Handpieces (Intensiv & Profin) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoYoung Dental Manufacturing Co. 1, LLC — Silver Fluoride Hypersensitivity Varnish (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoIntuitive Surgical, Inc. — da Vinci SP Advanced Access Port Kit (432701) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoAnhui Jbh Medical Apparatus Co., Ltd. — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoPhantomics, Inc. — Myomics (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoSuzhou Microport Orthorecon Co., Ltd. — MedalOne Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoQuality Electrodynamics — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoCepheid® — Xpert C. difficile/Epi (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoShenzhen Viatom Technology Co., Ltd. — Pulse Oximeter ( PO2, PO2A, PO2B) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k534d agoPromethean Restorative, LLC — DYNAMIS™ SI Screw System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 3, 2025

    30
    ›Mar 3, 2025device 510k531d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — EnergyLounger (TY-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k
    ← prev
    page 1 of 73
    next →
    531d ago
    Dia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k531d agoJLK, Inc. — JLK-SDH (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k531d agoOlympus Medical Systems Corporation — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k531d agoBracco Diagnostics, Inc. — HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k531d agoVarian Medical Systems, Inc. — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k531d agoBeijing Nubway S&T Co., Ltd. — Q Switched Nd:YAG Laser machine (QNHF-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k530d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Disposable Cytology Brush (AF series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k530d agoLimacorporate — Biolox® Delta Revision heads (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k530d agoCeevra, Inc. — Ceevra Reveal 3+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k530d agoAlphatec Spine, Inc. — Calibrate Interbody Systems (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k530d agoEuroteknika — iPhysio® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoVilex, LLC — TITANEX Screw Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoSiemens Healthcare GmbH — Prostate MR AI (VA10A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoPolynovo Biomaterials Pty, Ltd. — NovoSorb® MTX (510k cleared)

    Product code: QSZ. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoMako Surgical Corp. — Mako Total Hip Application 5.0 (510k cleared)

    Product code: OLO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoAsahi Intecc Co., Ltd. — CROSSLEAD 0.018inch (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoBeckman Coulter, Inc. — Access Cortisol; DxC 500i Clinical Analyzer (510k cleared)

    Product code: CGR. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k529d agoWell Lead Medical Co., Ltd. — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoDia Imaging Analysis, Ltd. — LVivo Seamless (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoDermaroller GmbH — XCELLARISPRO TWIST microneedling device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoLaboratorios Biogalenic S.A. DE C.V. — Sterile Water USP and Sterile 0.9% Normal Saline USP (510k cleared)Revalesio Corp

    Product code: FRO. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoCenterline Biomedical, Inc. — Intra-Operative Positioning System (IOPS®) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoXtreem Pulse, LLC — PureLift GLOW (510k cleared)

    Product code: NFO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoZimmer, Inc. — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoMedacta International S.A. — Versacem Acetabular Shell and Double Mobility HC Liners (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System (510k cleared)BECTON DICKINSON & CO

    Product code: LON. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k528d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution 5.1 (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k527d agoEpiwatch, Inc. — EpiWatch Monitoring System (510k cleared)

    Product code: POS. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    $ISRG394.51-1.68%
    $FRTRY
    $THCH
    $FMS23.77+0.59%
    $CODX1.51000.00%
    $BDX183.40+0.79%
    $MMSI90.76+0.29%