11 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIATHERMIC SNARES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UniTip Catheter
FDA UDI
Unisensor AG·07640172971659·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972274·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971642·
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
FDA 510(k)
FDA Class 2
·Cardiovascular
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
FERNO MODEL 40-OS CHAIR
FDA Adverse Event
Malfunction
·FERNO-WASHINGTON, INC.·Product code FPO·September 28, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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