8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ
FDA 510(k)
FDA Class 2
·Hematology
TLS SURGICAL MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTIMICROBIAL REMOVAL DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
PLATE, 8 HOLE STRAIGHT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·May 28, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 15, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 14, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
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