15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed ViewFlex Xtra ICE Catheter (D087031)
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL™ Sensi-Disc™ Cefuroxime 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316214·BD BBL™ Sensi-Disc™ Cefuroxime 30 µg
HERO 1, MODEL LY-ESB220
FDA 510(k)
FDA Class 2
·Physical Medicine
Magicore II System
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156726·Tesera-k ALIF, 31W X 26D, 21mm, 17° Trial
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151653·Tesera-k SA, 31mm X 26mm X 21mm, 17° Lordosis, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157471·Tesera-k ALIF, 31W X 26D, 21mm, 17° Broach
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
2.5MM DRILL BIT/QC/GOLD/110MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWE·March 16, 2016
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·August 18, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2013
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621
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