20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blood Tubing Lines for Hemodialysis AV06C-E
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
FDA 510(k)
FDA Class 2
·Microbiology
KEELER SLIT LAMP H-SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
COOK CELECT FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·November 14, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 1, 2011
ENDO DISSECT 5MM INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN·Product code GET·July 12, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
BD PHOENIX¿ PMIC-108
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 25, 2024
BD PHOENIX¿ PMIC-108
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 19, 2024
2.5MM DRILL BIT/QC/GOLD/180MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HWE·August 8, 2017
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012