17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cios Select (VA21) Flat Panel
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154156208·BONE SCREWS,CROSS-PIN,SELF-TAPPING
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613327419277·BONE SCREWS, CROSS-PIN, CUTTING FLUTE
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355790·Bone Screws, Cross-Pin
HEALTHY SLEEP APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 25, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·July 9, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
OSS TIBIAL POLY BEARING 18MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 2, 2016
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
FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·July 8, 2019
FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 3, 2019
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024