39 results
·
21ms
·
Sources: EU EUDAMED, US FDA
GSP NEONATAL TOTAL GALACTOSE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133552621·ELATION® MB Base Rx 022 UL/5-5 CS-BC HK
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807133652601·ELATION® MB Base Rx 022/L5 -22T
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807133652611·ELATION® MB Base Rx 022/L5 -22T HK
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
FDA 510(k)
FDA Class 2
·Cardiovascular
MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code LWJ·May 15, 2015
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOM PROXIMAL TIBIA JTS
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
PARADYM
FDA Adverse Event
Injury
·SORIN C.R.M., S.R.L.·Product code MRM·June 16, 2011
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTS·October 7, 2015
JTS DRIVE UNIT FOR CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 24, 2014
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
JTS EXTENDIBLE DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·December 23, 2014
DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·February 11, 2015