9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
FDA 510(k)
FDA Class 2
·Immunology
COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR
FDA 510(k)
FDA Class 2
·Radiology
US NANCY NAIL 450 20/10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·July 26, 2016
TI N FLEX ROD 150MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·January 14, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·November 30, 2010
LINOX SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 3, 2014
US NANCY NAIL 450 25/10
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HSB·June 1, 2017
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