13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
A-DEC 2170 DUO UNIT CUSP
FDA 510(k)
FDA Class 1
·Dental
N/A
FDA UDI
Tyber Medical, LLC·M695M9253140·
ALGODERM ALGINATE WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TI MULTILOC END CAP F/MULTILOCNAIL/5MM EXTENSION-STERILE
FDA Adverse Event
Malfunction
·SYNTHES SALZBURG·Product code HSB·October 21, 2016
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·December 15, 2011
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code MAV·December 15, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·January 17, 2013
ACCENT DR RF
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 15, 2014
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 27, 2018
TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE
FDA Adverse Event
Malfunction
·SYNTHES SALZBURG·Product code HSB·October 21, 2016
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021