9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRICHOMATE(R) SUPER
FDA 510(k)
FDA Class 1
·Microbiology
GC Initial™
FDA UDI
Gc America Inc.·J0228751381·GC Initial™ Zr-FS Shoulder Opaq. SO-38, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556708665·GC Initial™ Zr-FS Shoulder Opaq. SO-38, 20g
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
BOVIE ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·June 16, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 17, 2012