BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    Integrity-SI Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FlexiNylon cartridges Amhari/Purple Pink

    FDA UDI
    PERFLEX LTD·07290110500603·box of 6 identical cartridges sealed in aluminu...

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113720·PS-C Insert, Size 5 x 12mm

    FlexiNylon cartridges Amhari/Purple Pink

    FDA UDI
    PERFLEX LTD·07290110506544·5 identical cartridges sealed in a vacuum bag ;...

    Ambassador Cervical Plate System

    FDA UDI
    Choice Spine, LP·00840996160971·AMBASSADOR,DRILL,2.5x12

    CS2 HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

    FDA 510(k)
    FDA Class 1 ·Hematology

    OPT SLEEVE 12X100 STABILITY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019

    CIDEX OPA SOLUTION

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL LTD.·Product code MED·November 6, 2008

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·July 13, 2011

    ITREL II

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·July 12, 2013

    Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.

    FDA Recall
    Terminated ·Carestream Health, Inc.·Product code KPR·March 6, 2007

    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