8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS
FDA 510(k)
FDA Class 2
·Dental
CHURCHILL FEMALE LUER LOCK CAP
FDA 510(k)
FDA Class 2
·General Hospital
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 10, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWY·October 6, 2010
UNKNOWN MIS BUR
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD., INSTRUMENTS DIVISION·Product code HBE·December 5, 2012
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015