9 results
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26ms
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Sources: EU EUDAMED, US FDA
BASIN, ROUND WASH
FDA 510(k)
FDA Class 1
·General Hospital
SPONGE, CURITY WASHED GAUZE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THRUWAY GUIDE WIRES
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·March 7, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·September 26, 2012
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 15, 2010
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code NKB·June 28, 2013
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014