16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MIDWEST ONE
FDA 510(k)
FDA Class 1
·Dental
STABILITY FEMORAL PROSTHESIS W/HAP
FDA 510(k)
FDA Class 2
·Orthopedic
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·February 11, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 24, 2014
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 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 Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021