17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ERCHONIA EML LASER
FDA 510(k)
FDA Class 2
·Physical Medicine
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·June 4, 2010
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·August 27, 1999
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 8, 2010
SENSOR MMT-7020A ENLITE3 5PK US
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZP·December 27, 2017
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 26, 2020
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·May 4, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 3, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 22, 2011
ELECSYS PROLACTIN ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CFT·February 26, 2021
GOLD 2WAY SIL 5CC 14FR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FGH·August 5, 2015
VIDAS TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 25, 2020
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·August 19, 2021
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025