10 results
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25ms
·
Sources: EU EUDAMED, US FDA
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
Gafchromic™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00810106410227·
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029387·Bipolar Head Extractor, 28mm
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF
FDA 510(k)
FDA Class 2
·Radiology
MRI Dynamic Analysis Plus
FDA 510(k)
FDA Class 2
·Radiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 7, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
ROD CUTTER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXZ·December 30, 2021
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