BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    CONPHAR OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SnuggleFit

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377022579·SnuggleFit Infant Effort Belt - Grael

    ENOXAPARIN TEST CARD

    FDA 510(k)
    FDA Class 2 ·Hematology

    VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·March 28, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 24, 2010

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018