12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Noodle
FDA 510(k)
FDA Class 2
·Neurology
ambIT* PIB-PCA v1.5 System w/Male Filter Cass
FDA UDI
Avanos Medical, Inc.·00193494001292·ambIT* PIB-PCA v1.5 System w/Male Filter Cass
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00850000509047·PIB/PCA v1.5 Pain Control System-Basic
ELMED
FDA UDI
ELMED INCORPORATED·00842180124653·5 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, TR...
ELMED
FDA UDI
ELMED INCORPORATED·00842180119208·5 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, WI...
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDART 620
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code MFK·October 31, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
LOCKING DRILL GUIDE WITH TISSUE PROTECTION SLEEVE
FDA Adverse Event
Malfunction
·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code FZX·February 8, 2018
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