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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,404 8k filing · 2,000 device pma

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2026-07-20: 0 catalysts2026-07-21: 0 catalysts2026-07-22: 0 catalysts2026-07-23: 0 catalysts2026-07-24: 18 catalysts2026-07-25: 0 catalysts2026-07-26: 0 catalysts2026-07-27: 2 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 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,404
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Dec 2, 2024

    11
    ›Dec 6, 2024device 510k596d agoOxos Medical — MC2 Portable X-ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoBard Peripheral Vascular, Inc. — PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50- (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoStryker Corporation (Tornier, Inc.) — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoCercare Medical A/S — Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoMolecular Products , Ltd. — Rugged Oxygen Generator (ROG) (RO01-00001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoGS Medical Co., Ltd. — AnyPlus Navigated Instruments System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoBoston Scientific — WallFlex Biliary PLUS RX Stent System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoYukon Medical, LLC — SmartSiteTM Vented Vial Access Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoGlobus Medical, Inc. — ACTIFY™ Unicondylar Knee System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoLake Region Medical — PTFE Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2024device 510k594d agoSomnomedics GmbH — HomeSleepTest (HST, HST REM+) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 9, 2024

    39
    ›Dec 9, 2024device 510k593d agoEdwards Lifesciences — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k
    ← prev
    page 14 of 100
    next →
    593d ago
    Hartmann USA, Inc. — Atrauman® Ag (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k593d agoVerily Life Sciences, LLC — Verily Numetric Retinal Camera (510k cleared)TAE Life Sciences LLC

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k593d agoShenzhen Browiner Tech Co., Ltd. — Digital Radiography System (ManntiX B, ManntiX K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k593d agoGanshorn Medizin Electronic GmbH — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k593d agoSmith & Nephew, Inc. — TRIGEN META-TAN Trochanteric Antegrade Nail (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Dec 9, 2024device 510k593d agoRadformation, Inc. — AutoContour (Model RADAC V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoInstitut Straumann AG — Straumann® PURE Ceramic Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoIntuitive Surgical, Inc. — IRISeg (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoCarestream Health, Inc. — DRX-Revolution Mobile X-ray System (510k cleared)HEALTHSTREAM INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoJeisys Medical, Inc. — POTENZA (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoConcourse Assistive Technology Pty, Ltd. — Empulse M90 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoAerin Medical, Inc. — Aerin Console (510k cleared)AETHLON MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d 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 ↗
    ›Dec 10, 2024device 510k592d agoElos Medtech Pinol A/S — Elos Accurate® Hybrid Base™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoMerit Medical Systems, Inc. — Prelude Small O.D. Introducer Guide Wire (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoAnalog Devices — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (510k cleared)ANALOG DEVICES INC

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoSamsung Medison Co., Ltd. — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2024device 510k592d agoShantou Institute of Ultrasonic Instruments Co., Ltd. — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoVarian Medical Systems — Eclipse Treatment Planning System (18.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoMicrogenics Corporation — Alinity c Benzodiazepines Reagent Kit (510k cleared)

    Product code: JXM. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoMonarch Medical Technologies — EndoTool IV (3.1) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoRafael Medical Devices, LLC — VECTR – Video Endoscopic Carpal Tunnel Release System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoLife Spine, Inc. — Cervical Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoZuriMED Technologies AG — FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoZimmer, Inc. — OsseoFit Stemless Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoTechfit Digital Surgery, Inc. — TECHFIT DISRP® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoForeo, Inc. — FAQ™ (302) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoStryker Leibinger GmbH & Co KG — SternalPlate Expansion (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoPenumbra, Inc. — Access25™ Delivery Microcatheter (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoZhejiang Curaway Medical Technology Co., Ltd. — Radiofrequency Generator System, Cura RF Electrode (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 11, 2024device 510k591d agoTechnomed Europe — Disposable Subdermal Needle Electrode, Corkscrew (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d agoBredent GmbH & Co. KG — visio.lign color, visio.lign shield (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d agoEb Neuro S.P.A. — NExT Station; NExT Station Advanced (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d agoInfrascan, Inc. — Infrascanner Model 2500 (Model 2500) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d agoGe Medical Systems Information Technologies, Inc. — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d agoCmf Medicon Surgical, Inc. — Medicon Epiplating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    $GMED79.93+1.27%
    $EW91.33-2.47%
    $BSX44.38+1.84%
    $SNN30.25+5.29%
    $ISRG337.34+1.60%
    $MDCE0.00020.00%
    $PEN324.29-0.11%
    $HSTM
    $ADI
    $AEMD
    $MMSI73.110.00%