15 results · 23ms · Sources: EU EUDAMED, US FDA

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DIO SM IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014603636·Bariatric Boot Pads (pair)

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014606217·BARIATRIC STIRRUP BOOT PADS

SAUFLON MULTI LENS CARE SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 30, 2026

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·March 25, 2015

VITROS CHEMISTRY PRODUCTS VALP REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·April 26, 2013

LIGHTSPEED VCT

FDA Adverse Event
Injury ·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011

SOFTCLIX PLUS LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 22, 2008

EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·November 12, 2014

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·November 27, 2014

EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·November 24, 2014

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