BEUDAMED
    9 results · 42ms · Sources: EU EUDAMED, US FDA

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    RecoveryAir PRO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327599916·Le Fort I plate left

    HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEUROFORM 3 STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·October 24, 2008

    MCA SMALL APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·August 15, 2011

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 8, 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021