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

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    Filters Regulation: Us FDA ×

    MODEL ZY PACEMAKER LEAD-VARIOUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PREPARE CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACUMED CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 21, 2014

    MTOME ST HOLSTER/CABLES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code KNW·November 30, 2007

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012