BEUDAMED
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    Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs

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

    Search-Cyte Pool 0.8%

    FDA UDI
    Medion Grifols Diagnostics AG·07640137341596·Reagent Red Blood Cells for use in the detectio...

    NATURAL EXTENSIONS

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975030702·

    ORION MICRO CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOTEQUE VAGINAL PESSARIES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DIGITAL TENS UNIT, 2/4 ELECTRODES

    FDA Adverse Event
    Malfunction ·BIO PRETCH, INC.·Product code GZJ·October 6, 2014

    ENS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·October 27, 2008

    FLEXIMA¿ BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·August 16, 2011

    OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

    OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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