8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
JEJUNO-CATH KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER
FDA 510(k)
FDA Class 1
·Orthopedic
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code NAE·September 30, 2015
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 28, 2014
GPS PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·November 12, 2010
ANEURX ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 9, 2013
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015