15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vivid iq
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103951·6.7 mm Cannulated Over Drill, Large AO Quick Re...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311617060·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321617060·
Cervical Interbody 17mm x 13.5mm x 6mm
FDA UDI
XENCO MEDICAL LLC·B064XM21617061·
17mm X 13.5mm X 6mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XM31617061·
17mm X 13.5mm X 6mm CERVICAL INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XMPH31617061·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528108338·6.7 mm Cannulated Over Drill, Large AO Quick Re...
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CADWELL EASYNET OXIMETER MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 10, 2017
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 27, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
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