BEUDAMED
    13 results · 34ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Xpert Xpress CoV-2/Flu/RSV plus

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NA

    FDA UDI
    Medos International Sàrl·10886705031757·Sheath with 1 Rotating Stopcock compatible with...

    IBD-SCAN

    FDA 510(k)
    FDA Class 1 ·Immunology

    SURGIPHOR Wound Irrigation System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMP,TSV,MCOL MG,4.1MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 26, 2021

    IMP,TSV,MCOL MG,4.1MM,10M

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·February 22, 2024

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    CEFALY

    FDA Adverse Event
    Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

    CEFALY

    FDA Adverse Event
    Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

    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