9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331409·Cortical screw for use with tibial nails
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665582317·MIS Cannulated Screw, Ø4.5 x 50mm, Ø5.5mm Rod
CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
2ND SKIN MOIST BURN PADS WITH ALOE
FDA 510(k)
FDA Unclassified
·Unknown
COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 3, 2010
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·January 14, 2013
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 3, 2014
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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