BEUDAMED
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    PADSCAN HD SERIES BLADDER SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925016712·HARTMANN OFF. FCP,SERR 7X

    Oticon

    FDA UDI
    Oticon A/S·05707131255877·SENSEI, BTE 13 WL 90 EME

    MULTI-DIRECTIONAL SCREW

    FDA UDI
    Biomet Orthopedics, LLC·00880304533288·

    BACK-TEK

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LORDEX POWER TRACTION EQUIPMENT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    FIXED PERCUTANEOUS ROD INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE INC.·Product code NKB·May 23, 2013

    ATTAIN STARFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DIP·October 1, 2014

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·February 5, 2014

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024