BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sunkingdom Slit Lamp

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657013826·Hystero Sheath 2.9mm

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100981·DESMARRES LID RETRACTOR #3

    SYNOVIS COLLAGEN MATRIX (TBD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERLOC CLEAR SAFETY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 11, 2011

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 10, 2013

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·September 30, 2008

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    cobas 6000 analyzer series Operators Manual Roche cobas; 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