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

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    KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUADRA BROACH SIZE 0

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2019

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 29, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 10, 2011

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 29, 2008

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 25, 2019

    LINER: MPACT FLAT PE HC LINER 36/ER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020

    MPACT LINER FLAT PE HC LINER Ø 32/D

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 5, 2016

    CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 17, 2022

    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012