BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    HAND SPLINTS AND COMPONENTS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KNS·March 11, 1998

    HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code FMJ·April 15, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 1, 2015

    PRESIDIO 18 CERE 9MMX33CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·March 9, 2021

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015