BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    SMART Taylor Spatial Frame

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTERAL FEEDING

    FDA Adverse Event
    Malfunction ·MEDELA LLC·Product code KNT·March 23, 2022

    CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    VISENSIA, VISENSIA WITH ALERT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA Adverse Event
    Injury ·B. BRAUN MEDICAL, INC.·Product code FPB·June 4, 2010

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    SCORPIO NRG PS FEMORAL #4 RIGHT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018