10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
FDA 510(k)
FDA Class 2
·Cardiovascular
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall
Terminated
·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009
Bioseal Inc.
FDA UDI
BIOSEAL·00630094196466·Vascular Tubing
MYOPAC (TM), MODEL 9600
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Injury
·STRYKER SPINE-US·Product code NKB·May 6, 2024
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Injury
·STRYKER SPINE-US·Product code NKB·May 6, 2024
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
UNKNOWN DEPUY SZ. 32 LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 29, 2014