BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Empower H35

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304555174·

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868240010·

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    MAESTRO WRIST FRACTURE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNA-EXTOR II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTEX EPIDURAL CUSTOM CONTINUOUS TRAY

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code CAZ·June 21, 2019

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 17, 2014

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022

    STEALTHSTATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 11, 2019

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018