13 results · 28ms · Sources: EU EUDAMED, US FDA

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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