8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
FDA 510(k)
FDA Class 2
·Immunology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867125995·HEADLESS COMPRES SCRW 4.3X42MM
SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
CCS MODEL AV-102 IMPLANTABLE A-V DATA
FDA 510(k)
FDA Class 3
·Cardiovascular
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 7, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 10, 2012
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024