19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
FDA 510(k)
FDA Class 3
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450376232·
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·May 3, 2013
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·May 18, 2011
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·July 31, 2008
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 11, 2019
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 27, 2018
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·January 31, 2018
METASUL LDH, HEAD, 40, CODE F, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KXA·October 24, 2017
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 7, 2018
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 3, 2018
METASUL, HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 12, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 22, 2018
ECHO BI-MTRC MICR RP SO 5X73
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 6, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 14, 2018
METASUL LDH, HEAD, 48, CODE N, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 18, 2018