7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADDNOX (BPSPM1)
FDA 510(k)
FDA Class 2
·Neurology
E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
FDA 510(k)
FDA Class 2
·Orthopedic
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
FDA 510(k)
FDA Class 1
·General Hospital
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JDI·September 12, 2011
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 11, 2014
12/14 ARTICUL 40MM M SPEC-2
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code LPH·July 23, 2013
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021