8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VISIO-SEAL
FDA 510(k)
FDA Class 2
·Dental
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581162400001·A-FIT® 1. MOLAR UPR RGT SZ 24
EXPEDIO 500D R&F X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
FDA 510(k)
FDA Class 2
·Anesthesiology
OT PING METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 31, 2012
T4/WD2418/HD/ADULT/18/BH16/AT903/U2222C/COM/U550 9153639568
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 2, 2015
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018