9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRAPEZE BAR KNOCKED DOWN
FDA 510(k)
FDA Class 1
·General Hospital
GENTLERAY 980 DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOS Small Fragment Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 30, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 30, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·April 25, 2014
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·October 2, 2012
UNK DEPUY 3-PEG PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·July 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021