11 results · 23ms · 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.

Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)

FDA 510(k)
FDA Class 1 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814305·GENUMEDI PT SILVER R VII

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII

VASCUCOMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

DUCERA ALLCERAM

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2013

EVITA INFINITY V500

FDA Adverse Event
Malfunction ·DRAEGER MEDICAL SYSTEMS, INC.·Product code CBK·September 19, 2014

SENSOR ENLITE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 10, 2015

NEEDLE ECLIPSE 25X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 19, 2020

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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