10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OHIO TEMPERATURE SIMULATOR
FDA 510(k)
FDA Class 2
·General Hospital
Fresh Cells
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613334019·MDCK W24/18
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102930·DRYSDALE NUCLEUS MANIPULATOR
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
FDA 510(k)
FDA Class 2
·Orthopedic
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2008K HEMODIALYSIS SYS OLC/DIASAFE PLUS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 14, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 13, 2010
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Death
·MEDTRONIC CRYOCATH LP·Product code OAE·January 3, 2020
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·January 3, 2020