BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ANKLE/FOOT EXTERNAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707027867·WEB 1ST MOLAR BANDS n.UR 5

    ZOLL DENTAL

    FDA UDI
    Zoll-Dental·00840105223665·Weider Tongue Retractor, Child (in Handle)

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277116147·Bone Mill Pusher

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK

    SYNTHES TRANSLATING MAXILLARY DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    FRESENIUS 2008T HEMODIALYSIS MACHINE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS INC.·Product code NBW·April 9, 2014

    LAMITRODE 44

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 30, 2010

    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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015