BEUDAMED
    20 results · 20ms · Sources: EU EUDAMED, US FDA

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    EXSPIRON

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197029285·Fine Operating Scissor 12.0 c...

    INSERTER- STRAIGHT SHELL

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code OQG·May 4, 2015

    ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNTHES CRANIAL PLATES

    FDA 510(k)
    FDA Class 2 ·Dental

    CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MG II®

    FDA UDI
    Zimmer, Inc.·00889024186811·

    BD VACUTAINER URINE COMPLETE CUP KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·February 22, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2019

    ENDOPATH XCEL BLUNT TIP TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDOSURGERY, INC.·Product code GCJ·April 30, 2013

    CAREASSIST

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·August 15, 2008

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·June 7, 2011

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JTW·February 10, 2021

    NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

    FDA Enforcement
    Class III ·Terminated·Nidek, Inc.·January 8, 2020

    Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325 mg), Product Code: L202L.

    FDA Enforcement
    Class II ·Terminated·Total Resources Intl·May 25, 2022

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: 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. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015