10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Ertapenem 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902321743·BD BBL™ Sensi-Disc™ Ertapenem 10 µg
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
FDA 510(k)
FDA Class 2
·Radiology
MULTICHEM WBT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·November 4, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 2, 2011
LUMAX 540 VR-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code LWS·July 17, 2013
OT ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 14, 2011
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024