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

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    COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SleepWeaver Elan - Mask Only - Regular - Camo

    FDA UDI
    CIRCADIANCE, LLC·B036100656·SleepWeaver Elan Cloth Nasal PAP Mask Only - Re...

    DEBAKEY VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006560·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK

    DEBAKEY VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002920·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK

    VOLKMAN RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049284·VOLKMAN RETRACTOR SHARP PRONGS

    microTargeting™ Electrode

    FDA UDI
    FHC, INC.·10873263006563·microTargeting™ Electrode, back loaded, non ste...

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494462368·Bone Chisel Awl Knurled Handle Steel D 3.0mm, ...

    MEDCOM RT-VIEWER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMBRYON GIFT TRANSFER CATHETERS/SETS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    R. POON·Product code ITJ·May 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    SYNERGY

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 17, 2011

    AVAN REINF RING SS 48/58MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 14, 2015

    Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems 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 analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018