BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    FloPatch FP120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517302823·CoRoent XL-K Keel Cutter, 14mm Short

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154274758·BONE ANCHOR SCREWS,SELF-TAPPING

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619060268·TriOx™ SvO2/CCO PA Catheter, 8F, 110cm, Q-Tip

    Kleiner KG2 system

    FDA UDI
    Baat Medical Products B.V.·08720246782998·Trial

    TASTES GREAT

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730004475·Alginate Flavoring Dreamsicle 2 fl oz per bottle

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00810065990617·Squadron Anatomical Bullet Nose PLIF Cage, 25mm...

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00811771037535·Squadron Lordotic Bullet Nose PLIF Cage, 25mm x...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011251114200·ceraMotion® Ti Dentin Modifier Chroma orange, 2...

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00811771035739·Squadron Parallel Bullet Nose PLIF Cage, 25mm x...

    Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    8F TRIOX SVO2/CCO PA CATHETERS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DQE·April 20, 2016

    8F TRIOX SVO2/CCO PA CATHETERS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DQE·April 20, 2016

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 17, 2011

    VANGRD ANT STBLZD BRG 10X71

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·November 14, 2014

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY·Product code GCT·August 9, 2011

    TOTAL ASR ACET IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 29, 2013

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024