8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLUMBUS TOTAL KNEE SYSTEM (CR)
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 14, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 27, 2012
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