29 results · 36ms · Sources: EU EUDAMED, US FDA

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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