8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATRAUMATIC TIP ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GAUZE SPONGES, INTERNAL AND EXTERNAL
FDA 510(k)
FDA Unclassified
·Unknown
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Enforcement
Class II
·Terminated·R82 A/S·May 22, 2019
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·December 6, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 30, 2013
V200 VENTILATOR
FDA Adverse Event
Malfunction
·REPIRONICS CALIFORNIA INC·Product code CBK·July 15, 2014
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Recall
Terminated
·Product code INM·March 28, 2019