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

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    POOL NORM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925017061·RICHARDS FLUOROPLASTIC BUCKET HANDLE PROTHESIS,...

    MAXIM VI KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304205499·

    NOVASYS TRANSURETHRAL RF SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·June 3, 2007

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·October 14, 2011

    HEMOCHRON SIGNATURE MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·April 16, 2010

    BATHLIFT BLISS RECLINER US AB

    FDA Adverse Event
    Malfunction ·HANDICARE·Product code FSA·May 23, 2013

    ZMR HIP SYSTEM TAPER STEM

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LPH·May 26, 2011

    L-CATH S/L 28 GA

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code LJS·October 9, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 5, 2015

    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021