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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,417 8k filing · 2,000 device pma

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2026-07-27: 4 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 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: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,417
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Feb 24, 2025

    30
    ›Feb 27, 2025device 510k515d agoGleamer Sas — ChestView US (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoVascutek, Ltd. — Gelweave™ Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoIline Microsystems, S.L. — microINR System (510k cleared)

    Product code: GJS. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoIcotec AG — VADER® Pedicle System and VADER®one Pedicle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoXaga Surgical — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoBecton Dickinson Infusion Therapy Systems, Inc. — PIVO™ Pro Needle-free Blood Collection Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoThermo Fisher Scientific — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k515d agoBrosmed Medical Co., Ltd. — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k514d 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 510k514d 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 510k514d agoBasis Medical — Seclusion Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d 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 510k514d agoPhantomics, Inc. — Myomics (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k514d 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 510k514d 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 510k514d agoCepheid® — Xpert C. difficile/Epi (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k514d 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 510k514d 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

    20
    ›Mar 3, 2025device 510k511d 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 28 of 100
    next →
    511d 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 510k511d agoJLK, Inc. — JLK-SDH (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k511d 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 510k511d 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 510k511d 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 510k511d 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 510k510d 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 510k510d agoLimacorporate — Biolox® Delta Revision heads (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k510d agoCeevra, Inc. — Ceevra Reveal 3+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k510d agoAlphatec Spine, Inc. — Calibrate Interbody Systems (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k510d agoEuroteknika — iPhysio® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k509d agoVilex, LLC — TITANEX Screw Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k509d 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 510k509d agoPolynovo Biomaterials Pty, Ltd. — NovoSorb® MTX (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k509d 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 510k509d 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 510k509d 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 510k509d 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 510k508d agoDia Imaging Analysis, Ltd. — LVivo Seamless (510k cleared)

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

    full page →fda device 510k ↗
    $THCH
    $FMS24.59+0.61%
    $FRTRY
    $TMO447.81+1.31%
    $ISRG337.50+1.65%
    $MMSI74.32+1.66%
    $CODX2.1000-4.98%