BEUDAMED
    15 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.

    TRIAGE TOX DRUG SCREEN, MODEL 94400

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019

    REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HBS HEADLESS BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDICAL COMPRESSOR

    FDA Adverse Event
    Malfunction ·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·April 5, 2013

    RESERVOIR 3CC

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 8, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·June 12, 2008

    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018