12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPANION LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640090·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78615031·Sprint II Bracket Roth .018" mand. 4 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78615030101·Sprint II Bracket Roth .018" mand. 4 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78615030051·Sprint II Bracket Roth .018" mand. 4 right w. hook
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78615031001·Sprint II Bracket Roth .018" mand. 4 right w. hook
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ORION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·June 10, 2014
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·October 8, 2010
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 28, 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