12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Asept Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
FDA 510(k)
FDA Class 2
·Radiology
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 27, 2018
CRYOCYTE FREEZING CONTAINER, 50 ML W/LABEL POCKET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KSR·November 12, 2008
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 26, 2011
INGENIO
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NVZ·July 11, 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
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 15, 2019
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020