10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
FDA 510(k)
FDA Class 2
·Hematology
K883239
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009
CAPD DISP DISCONNECT, UV FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008
LSFG-NAVI
FDA 510(k)
FDA Class 2
·Ophthalmic
Active-V Total Knee System; World Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTH CORPORATION·Product code FRN·January 23, 2014
ARTISTE MV SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·November 30, 2012
TURON
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSD·September 30, 2010
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 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