9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ANTI-DSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052025151·Handpiece, manual operation, stainless steel
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450400920·
PLEXOLONG SETS
FDA 510(k)
FDA Class 2
·Anesthesiology
Hemochron Signature Elite
FDA 510(k)
FDA Class 2
·Hematology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·January 14, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORP·Product code LZG·November 19, 2010
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 3, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024