155 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·LASER WELDING/RHAR,PMMA HAPTICS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS KR2V, SK21V, S2BV
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·20842209121827·
HYPODERMIC NEEDLES & STYLETS
FDA 510(k)
FDA Class 2
·General Hospital
TENDRIL MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·May 15, 2017
TENDRIL MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·May 15, 2017
ASSURITY MRI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·April 20, 2017
ENDURITY MRI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·May 16, 2018
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
DLT TS CER HD 12/14 40MM +1.5
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LZO·December 29, 2014
PINNACLE 300 ACET CUP 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 29, 2014
ALTRX +4 10D 40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·December 29, 2014
ENDURITY PACEMAKER, DR, MRI RESTRICTED
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·March 17, 2022
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 30, 2014
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·November 15, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·September 15, 2010
DCM MAXIM PRIMARY LIPPED BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 7, 2017
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Endurity MRI ,Assurity MRI Pacemaker