BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    NOVAPROBE LED LIGHT SOURCE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012172·WIRE CRIMPING ALLIGATOR FORCEPS 4 MM X .8 MM JAW

    Oticon

    FDA UDI
    Oticon A/S·05707131255860·SENSEI, BTE 13 WL 90 BU

    Intramedullary Plugs

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575036912·Intramedullary Plug Impactor, threaded, L=400 m...

    AUDIT MICROCV RF/CRP LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STERRAD CYCLESURE BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 18, 2016

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 19, 2016

    LANX SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·LANX, LLC·Product code MNI·May 23, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·October 1, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 22, 2020

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 30, 2015

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015