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

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    DSL ESTRONE (DSL 8700)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Barco

    FDA UDI
    Barco NV·05415334050082·MDSC-8532 SSTF M2

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128472·Congruent Tibial Insert, Size 1 x 13mm

    Cranial Fusion

    FDA UDI
    Life Spine, Inc.·00190837085315·

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180159433·Brooks Style” non-sterile, reusable, medical-gr...

    CO2 INSUFFLATOR 1100

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    T.C.S. TOTAL CONTACT SEAT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/260

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·January 10, 2019

    NOVAMAX LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP·Product code NBW·January 25, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·December 21, 2010

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 15, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022