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

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    JIAJIAN CMN STIMULATOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502524·DELTA XTEND Lateralized Glenosphere +8mm Eccent...

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502517·DELTA XTEND Lateralized Glenosphere +8mm Eccent...

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502531·DELTA XTEND Lateralized Glenosphere +8mm Standa...

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295502548·DELTA XTEND Lateralized Glenosphere +8mm Standa...

    COMPUTED DENTAL RADIOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Dental

    CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 24, 2013

    QUADRA ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 6, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 15, 2020

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·February 9, 2023

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·December 6, 2024

    SLEEK OTW PTA CATHETER

    FDA Adverse Event
    Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 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