13 results
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28ms
·
Sources: EU EUDAMED, US FDA
PLUME MASTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NOMOS MOTORIZED CRANE II
FDA 510(k)
FDA Class 2
·Radiology
WARM TOUCH II COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 14, 2014
EPIX LAPAROSCOPIC GRASPER, 5MM X 35CM
FDA Adverse Event
APPLIED MEDICAL RESOURCES CORP.·Product code GCJ·January 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·November 3, 2010
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024