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

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    WATER FILLED TEETHER

    FDA 510(k)
    FDA Class 2 ·Dental

    Young

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302730521054·Young Prophy Cup, Soft, Long, Gray Spiraled Tur...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809848960·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...

    P102,S102 DUAL,1 FT, DP(STEEL),CURBELL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828178082·P102,S102 DUAL,1 FT, DP(STEEL),CURBELL

    SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROMUS ELEMENT ?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 11, 2013

    LANDMARX EVOLUTION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 1, 2011

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO·Product code FII·May 12, 2008

    Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-125.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

    DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

    FDA Recall
    Terminated ·R4 Vascular Inc·Product code MSD·May 3, 2011