BEUDAMED
    16 results · 30ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST

    FDA 510(k)
    FDA Class 2 ·Dental

    miniARM™

    FDA UDI
    LSI Solutions, Inc.·00850200006858·miniARM™ INSTRUMENT HOLDER LEFT

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756045759·Foley Catheter with Temperature Sensor

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756399296·Foley Catheter with Temperature Sensor

    DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PDT DOSECALCULATOR, MODEL 80000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 1, 2013

    LINEAR 3-6

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 13, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 23, 2012

    ALIGN S URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·April 24, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·April 22, 2011

    INVACARE WALKERS

    FDA Adverse Event
    Injury ·INVACARE CORP. PATIENT AIDS MFG.·Product code ITJ·July 16, 2008

    PROCEED MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 31, 2019

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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