13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
FDA 510(k)
FDA Class 1
·Microbiology
HYPO-GRIP
FDA 510(k)
FDA Class 1
·General Hospital
QHRV 1 - HEALTH ASSESSMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ISOMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 27, 2008
INTRATHECAL CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 27, 2008
ISOMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 27, 2008
INTRATHECAL CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 27, 2008
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 9, 2014
ENDOSTAT ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 25, 2010
MYNX CADENCE
FDA Adverse Event
Malfunction
·ACCESS CLOSURE·Product code MGB·December 6, 2012
BD PHASEAL¿ INFUSION ADAPTER C100
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 26, 2023
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·February 9, 2026
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025