BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304

    FDA 510(k)
    FDA Class 2 ·Radiology

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033149409·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033149393·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033149386·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033219089·

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033149362·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033149300·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0104100·Caddie Lid, Tulip and Domino Connectors

    ONTRAK TESTCUP 502, MODEL 3016641

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CONVERTORS EQUIPMENT DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AXXENT FLEXISHIELD MINI (K090417)

    FDA Adverse Event
    Injury ·XOFT, INC.·Product code IXI·January 7, 2011

    Inogen Rove 4

    FDA UDI
    Inogen, Inc.·00817131020414·The Inogen Rove 4™ Portable Oxygen Concentrator...

    CAMERA, POLARIS SPECTRA

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 2, 2019

    CAMERA HEAD

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·September 16, 2024

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 19, 2013

    SHUNT SENSOR SYS500

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DRY·March 2, 2011

    Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025