8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
FDA 510(k)
FDA Class 2
·General Hospital
ALCO-SCREEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PNEUMOPERITONEUM INSUFFLATION NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·November 5, 2008
COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 17, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 11, 2013
Allura Xper FD20/15; System Code: 722058;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025