BEUDAMED
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    EchoGo Core (2.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMPRESSIBLE LIMB THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ASTRALIS 10, MODELS # 559588, 561859

    FDA 510(k)
    FDA Class 2 ·Dental

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 27, 2008

    FRACTAL LASER

    FDA Adverse Event
    Injury ·Product code ONG·August 10, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    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