7 results
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19ms
·
Sources: EU EUDAMED, US FDA
ShiNeo Silicone Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENGLER 25K SERIES ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HSB·November 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018