BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B

    FDA 510(k)
    FDA Unclassified ·Unknown

    MGD 2621L MEDICAL GREYSCALE DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPUY 1 GENTAMICIN BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    FDA Adverse Event
    Other ·DALE MEDICAL PRODUCTS, INC.·Product code CBH·April 29, 2011

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 24, 2008

    MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LIT·April 29, 2003

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018