9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
RPMI-1640 MEDIUM, CATALOG NO. 210-3523
FDA 510(k)
FDA Class 1
·Hematology
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799003881·
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799009166·
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
MULTLINK CABLE AND LEADWIRE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 10, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWQ·October 14, 2010
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·December 21, 2012
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 19, 2015