12 results
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34ms
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Sources: EU EUDAMED, US FDA
TRACHEAL TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209115242·
Legacy™ Angled Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307110705·
LEGACY ANGLED ABUTMENT
FDA Adverse Event
Malfunction
·IMPLANT DIRECT SYBRON MANUFACTURING LLC·Product code NHA·April 17, 2020
Legacy™ Zirconia Angled Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307112129·
Legacy™ Zirconia Angled Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307112112·
i-STAT hs-TnI cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 6, 2014
ACCU-CHEK ® INFORM TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 5, 2010
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Injury
·ACCESS CLOSURE, INC.·Product code MGB·August 2, 2012
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021