12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Cefepime 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316962·BD BBL™ Sensi-Disc™ Cefepime 30 µg
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
VESALIUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL SENSI-DISC CEFEPIME - 30 G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·April 9, 2021
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
ALARIS SECONDARY SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·June 8, 2017
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 14, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 22, 2011
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 17, 2013
BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022