7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HOT OR HEAT PACK
FDA 510(k)
FDA Class 1
·Physical Medicine
CXR16
FDA 510(k)
FDA Class 2
·Radiology
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
FDA 510(k)
FDA Class 2
·Microbiology
AIR DERMATOME KIT
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·April 2, 2014
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 30, 2012
GENERATOR, OXYGEN, PORTABLE
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code CAW·September 29, 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