332 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040018422·Neck Pads Black W/Teal
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·February 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 12, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·June 17, 2008
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 20, 2026