8 results
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26ms
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Sources: EU EUDAMED, US FDA
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
FDA 510(k)
FDA Class 1
·Ophthalmic
Rib Spreader
FDA UDI
KOROS U.S.A., INC.·10840199536204·Rib Spreader Pediatric Size 4, 3-3/4" Arm Lengt...
PLAYTEX EMBRACE PETITE BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
InnoSEAL Hemostatic Pad
FDA 510(k)
FDA Unclassified
·Unknown
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 7, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015
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