13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Philips
FDA UDI
Sbo Hearing A/S·05714464032563·HEARLINK 9030 MNR T TP
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
FDA 510(k)
FDA Class 2
·Neurology
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 29, 2014
ASCENSION SILICON PIP
FDA Adverse Event
Injury
·ASCENSION ORTHOPEDICS, INC.·Product code KYJ·August 12, 2011
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·July 16, 2013
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
CODMAN Disposable Perforator 9mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025