BEUDAMED
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    Examination gloves-Type A(Latex gloves)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Avex CX

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205108234·Avex CX .018 UL4,5 D/HK (-7°T 0°A)

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100762·VBR,SPACER,12X14X17,0 DEG

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688046584·

    Twin Tip Edge Sidewinder

    FDA UDI
    TP ORTHODONTICS INC·00192029028001·CCW Oriented

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376266190·4.0mm Variable Angle, Self Tapping Screw, Dual ...

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981057404·Screw - Self-Drilling - Variable - 4.0x17mm

    Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACTOnco, ACTOnco IVD

    FDA 510(k)
    FDA Class 2 ·Pathology

    AMK POLY PATELLA 9.5 X 38MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 27, 2008

    ULTRAVAC 90 WITH INTEGRATED CABLE

    FDA Adverse Event
    Other ·ARTHROCARE CORPORATION·Product code GEI·August 3, 2011

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI 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

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017