9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIQUID SCINTILLATION COUNTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471179789·Anatomical Molar Bands, Lower Right 1St Molars,...
ULTRAZYME ALKALINE PHOSPHATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PANORAMIC, MODEL 200MA
FDA 510(k)
FDA Class 2
·Ophthalmic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
MITEK MILAGRO INTERFERENCE SCREW, 9 X 30MM
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·September 26, 2012
MAXIMO II VR
FDA Adverse Event
Death
·MEDTRONIC S.A.·Product code LWS·July 19, 2010
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014