10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Shannon Recta Larga Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289600·
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115953·DELTA Xtend CTA HEAD TRIAL DIA 52 X 26MM
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115946·DELTA Xtend CTA HEAD TRIAL DIA 52 X 21MM
DYNASENSE SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
DB-Orthopedics
FDA 510(k)
FDA Class 2
·Orthopedic
CORFLO CUBBY DUAL PORT STANDARD BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 28, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 1, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 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