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

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    ISOLA(TM) SPINE SYSTEM - ILIAC SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962159255·BLUNT OBTURATOR FOR 2MM OPERATING SHEATH, COLOR...

    NONE

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009

    EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIM·January 11, 2013

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·November 24, 2010

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 3, 2014

    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 31, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025