11 results
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18ms
·
Sources: EU EUDAMED, US FDA
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603131·Sprint II Bracket Roth .018" max. 3 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603131001·Sprint II Bracket Roth .018" max. 3 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603130051·Sprint II Bracket Roth .018" max. 3 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603130101·Sprint II Bracket Roth .018" max. 3 right
KIT, PREP, INSPIRON IV
FDA 510(k)
FDA Class 1
·General Hospital
Xenco Medical Cervical Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·October 7, 2010
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Other
·MOOG MEDICAL DEVICES GROUP·Product code LZH·November 21, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
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