7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
LASTOBAND ADHESIVE BANDAGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACUMEN SURGICAL NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
SCRDRIVER SHAFT T25 STRAIG
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·October 11, 2012
CARDIA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024