9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983046·posteriors; shade B1; size S; upper jaw
FORA TELEHEALTH SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
FDA 510(k)
FDA Class 2
·Radiology
NexGen®
FDA UDI
Zimmer, Inc.·00889024218345·
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·February 28, 2013
SYSTEM 7 SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·August 6, 2014
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code LGW·February 4, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024