8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AS/3 CARDIAC OUTPUT & SVO2 MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
Titan Reverse Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556864326·HEX DRIVER FOR 4.5MM SCREWS
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780467922·Hex Driver for 4.5mm Screw
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
FDA 510(k)
FDA Class 2
·Cardiovascular
EzRay Air (Model VEX-P300)
FDA 510(k)
FDA Class 2
·Dental
THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 26, 2014
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 14, 2013
OPTI-FREE REPLENISH
FDA Adverse Event
Injury
·ALCON-FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·January 12, 2011