12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OpenSensorX Series
FDA 510(k)
FDA Class 2
·Dental
ELMED
FDA UDI
ELMED INCORPORATED·00842180107304·5 MM DIA., 33 CM INSULATED SPATULA ELECTRODE, S...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776155964·33CM SPATULA LAPAROSCOPIC ELEECTRODE SIDE MOUNT...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134552·LATERAL,DISSECTOR,PENFIELD,ANGLED
VILET VILET QUICK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
ADVIA CENTAUR TROPONIN ULTRA ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·October 30, 2008
CUSTOM DEFIND PRODUCT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·August 23, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code ODG·April 5, 2023
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021