7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CROUCH CORNEAL PROTECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
ATHENA PELVIC MUSCLE TRAINER II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 15, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·September 5, 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