8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRAVASCULAR ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
artegral life
FDA UDI
Merz Dental GmbH·D7091993463·anteriors; shade D3; mould CM
IVT INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 7, 2013
UNKNOWN
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·February 11, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 2014
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