8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SHILEY QUICK DISCONNECT ASSEMBLY
FDA 510(k)
FDA Class 1
·Cardiovascular
Microlife Non-Contact Infrared Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
PLS PORTABLE LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TAXUS? LIBERTÉ?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 15, 2012
GENESIS 8-CHANNEL IPG
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 4, 2010
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024