8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRIFLEX SURGEON'S GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103043·BADAWY FEMTO SPLITTER, RIGHT
FREEPRINT® splintmaster
FDA 510(k)
FDA Unclassified
·Unknown
ALTATEC CERAMIC ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 27, 2014
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 13, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015