BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    REAGENT, RUSSEL VIPER VENOM - LA CONFIRM

    FDA 510(k)
    FDA Class 1 ·Hematology

    NexxZr™ T / D-100-30-NT-B200-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112866·

    SENOVA(R) BLOOD GLUCOSE MONITOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIQUIBAND DUAL, MODEL LBD 001

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

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code DTB·October 1, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 16, 2011

    DIMENSION EXL WITH LM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 28, 2016

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 28, 2016

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014