21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
FDA 510(k)
FDA Unclassified
·Unknown
PONTIC PAINT
FDA 510(k)
FDA Class 2
·Dental
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 28, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·October 19, 2016
SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
FDA Adverse Event
Injury
·MEDTRONIC MEXICO·Product code KRH·September 7, 2017
SIMULUS SEMI-RIGID ANNULOPASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 12, 2017
UNKNOWN DEPUY INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 12, 2008
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
RING 620RG31 DURAN ANCORE ANNULOPLASTY C
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·March 23, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2015
SIMULUS SEMI-RIGID ANNULOPASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 12, 2017
SIMULUS SEMI-RIGID ANNULOPASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 20, 2017
RING PROFILE 3D 28MM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 4, 2017
RING 620RG35 DURAN ANCORE ANNULOPLASTY C
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·February 1, 2017
UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025
BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024
CG FUTURE BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·March 14, 2017