8 results
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25ms
·
Sources: EU EUDAMED, US FDA
TWIN GOT-AST IFCC/GPT-ALT IFCC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642391·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PINPOINT Endoscopic Fluorescence Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 8, 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