BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Synthes GmbH·10886982153500·4.5MM CORTEX SCREW 36MM

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100953·VBR,SPACER,12X14X36,0 DEG

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020640·FPS 4.0mm x 36mm Standard Screw

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586023835·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074940·FPS 4.0 x 36mm Screw Sterile Qty 2

    Carnation Ambulatory Monitor (CAM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    INVICTUS

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code NKB·November 21, 2024

    HALO PKS CUTTING FORCEPS

    FDA Adverse Event
    Other ·GYRUS MEDICAL INC.·Product code GEI·August 3, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 24, 2014

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·July 3, 2013

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    UROSKOP Omnia Max. Model Number: 10762473

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017