9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
1208 BETACORD AND 1208 BETCORD M
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·10842209113573·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111193941·MCCREA XS URETHRAL SOUND 34FR
XprESS Multi-Sinus Dilation System
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
FDA 510(k)
FDA Class 2
·Radiology
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 5, 2014
DELTA CER HEAD 12/14 32MM +1
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code LZO·November 30, 2012
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·September 29, 2010
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020