29 results
·
36ms
·
Sources: EU EUDAMED, US FDA
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT
NEOCALEX
FDA 510(k)
FDA Class 1
·Dental
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 20, 2016
VG DA 360 O/S TIB TRAY COCR 63
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 2, 2016
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 25, 2020
VG DA360 TIB BRG ARCM 71/75X24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 7, 2016
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 4, 2020
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 79/83 X 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 6, 2016
VG DA 360 O/S TIB TRAY COCR 71
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 1, 2016
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 1, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·September 16, 2014
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 13, 2011
VG DA 360 O/S TIB TRAY COCR 67
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 3, 2018
VANGUARD DA360 TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 14, 2017