BEUDAMED
    16 results · 21ms · 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 ×

    ZUMA, MODEL 55-XXXX/56-XXXX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PB560 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 22, 2011

    PB560 VENTILATOR X1

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    DELTA CER FM HD 036/-4MM 12/14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 23, 2026

    UNKNOWN AVANTAGE HEAD

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 6, 2025

    UNKNOWN DEPUY SZ 3 AMK CONGRUENCY TIBIAL INSERT

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 29, 2013

    INTRINSIC

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·May 10, 2011

    MAMMOTOME EX HOLSTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code KNW·July 25, 2008

    BIOLOX DELTA CERAMIC FEMORAL HEAD

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

    32MM COCR BIOMET FEM HD -3 NK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 30, 2025

    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