14 results · 26ms · 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.

DAR-8000I

FDA 510(k)
FDA Class 2 ·Radiology

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704283518·DAVIS RETRACTOR DOUBLE ENDED 6"

MILLENNIUM

FDA UDI
Avalign Technologies, Inc.·00190776313524·Davis Retractor, Double-ended,

SENOVA(R) BLOOD GLUCOSE MONITOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FIRST CHOICE & FIRST CHOICE PLUS

FDA 510(k)
FDA Class 2 ·Neurology

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013

PROGRAMMING WAND

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·May 20, 2008

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·April 12, 2011

BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·July 23, 2025

BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·November 13, 2024

BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·September 30, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2025

BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·January 21, 2025

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