21 results
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29ms
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Sources: EU EUDAMED, US FDA
DRAGER INCUBATOR 8000 IC
FDA 510(k)
FDA Class 2
·General Hospital
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182947·Femoral component, TiNbN coating, uncemented, C...
THROMBELASTOGRAPH
FDA 510(k)
FDA Class 2
·Hematology
DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS
FDA 510(k)
FDA Class 2
·Neurology
CC TIBIAL INSERT SZ 4, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 2, 2022
APEX KNEE SYSTEM
FDA Adverse Event
Injury
·OMNLIFE SCIENCE, INC.·Product code JWH·February 4, 2013
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·January 10, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 23, 2014
CC TIBIAL INSERT SZ 3, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
CC TIBIAL INSERT SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 7, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 25, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 30, 2025
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
CC TIBIAL INSERT SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
TRAPEZOID TIBIAL TRAY SZ 5F/5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 25, 2024
TRAPEZOID TIBIAL TRAY SZ 5F/5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 30, 2025
CC FEMORAL SZ 5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 27, 2025
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 9, 2024
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·August 30, 2021