8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EEE
FDA 510(k)
FDA Class 1
·Anesthesiology
ZAVATION
FDA UDI
Zavation LLC·00842166117204·Polyaxial Screw 3.5mm x 40mm
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
FDA 510(k)
FDA Class 2
·General Hospital
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 10, 2011
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 23, 2014
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 27, 2014