8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
IMMULON SUBSTRATE REMOVAWELL STRIPS
FDA 510(k)
FDA Class 1
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707063667·TUBE MIM 22 T-20 R+8 LL
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 3, 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