11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LABOR-DELIVERY STRETCH/BED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEONE SPA
FDA UDI
LEONE SPA·08033707066279·KOBAYASHI PREFORMED WIRE 012"
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108079·MCPHERSON NEEDLE HOLDER CURVED
BIS
FDA UDI
Covidien LP·10884521553170·BIS LoC 4 Channel Refurbished, Software Version...
GC Ortho Chain
FDA UDI
Gc Orthodontics America Inc.·E53586103000011·GC ORTHO CHAIN Clear Long
BIOBLANKET SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATLANTIS Abutment for CONELOG implant
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 7, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 3, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012