23 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO FOCUS
FDA 510(k)
FDA Class 2
·Dental
PURESPERM WASH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REPROCESSED LINVATEC ARTHROSCOPIC BURS
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012
UNKNOWN LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 5, 2024
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GEI·March 27, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 17, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CANADA·Product code LFR·March 31, 2008
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code PZE·May 10, 2022
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012
AlternatiV+ Screw-In Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Fixone Hybrid Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Screw-In Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
AlternatiV+ Max Knotless Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Fixone Biocomposite Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Push-In Suture Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Knotless Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Dual Thread Screw-In Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025