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

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    V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U

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

    SleepWeaver Elan - Mask Only - Regular - Leopard

    FDA UDI
    CIRCADIANCE, LLC·B036100657·SleepWeaver Elan Cloth Nasal PAP Mask Only - Re...

    DEBAKEY MORRIS VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002937·DEBAKEY MORRIS VASCULAR CLAMP ANGLED 2X3 JAW CU...

    DEBAKEY MORRIS VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006570·DEBAKEY MORRIS VASCULAR CLAMP ANGLED 2X3 JAW CU...

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001324·Invue Max, Three Level ACP, 57mm

    microTargeting™ Electrode

    FDA UDI
    FHC, INC.·10873263006570·microTargeting™ Electrode, back loaded, non ste...

    OLYMPUS ENDOSCOPE REPROCESSOR

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FEB·March 14, 2023

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494462375·Probe Knurled Handle Steel D 3.0mm, WL 260mm

    LUER ACCESS UNIVERSAL VIAL ADAPTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COPELAND MB RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·May 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    RESTORE PRIME ADVANCED

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

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    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