9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P.C.A. MODULAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CRANIAL MAP NEURO
FDA 510(k)
FDA Class 2
·Neurology
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EXTENSION SET 30IN
FDA Adverse Event
Malfunction
·HOSPIRA INC.·Product code FPA·June 3, 2009
APM/AIM PUMP SET W/C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 28, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·November 16, 2010
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 14, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020