10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANAX 5.5 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Taxo™ Differentiation Discs for Urea
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902317371·BD BBL™ Taxo™ Differentiation Discs for Urea
SUPERNOVA C5 MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
FDA 510(k)
FDA Class 1
·Microbiology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
OXIMAX N-560 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·July 12, 2013
UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025
BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022