BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ds Head 32ch 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORTRAK ENTERAL ACCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIRMINGHAM HIP RESURFACING

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·October 24, 2018

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·August 12, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTP·July 2, 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