6,515 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 18, 2025
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 9, 2014
HU-FRIEDY MFG. CO., LLC
FDA Adverse Event
HU-FRIEDY MFG. CO., LLC·Product code DYX·December 15, 2016
SYMPHONY
FDA Adverse Event
Injury
·ELA MEDICAL·Product code DYX·June 7, 2005
WIRE
FDA Adverse Event
Injury
·SYNTHES USA·Product code DYX·December 20, 2012
VA LOCKSCR Ø2.4 SELF-TAP L12 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DYX·December 21, 2012
30" PRESSURE INJECTOR LINE
FDA Adverse Event
Malfunction
·MEDEX·Product code DYX·August 10, 2005
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code LHI·June 10, 2014
Lock, Wire, And Ligature, Intraoral
FDA classification
FDA Class 2
·Lock, Wire, And Ligature, Intraoral
DAX EYEWEAR
FDA registration
DAX EYEWEAR·1 product·🇺🇸 United States
SOLO-DEX
FDA registration
SOLO-DEX·1 product·🇺🇸 United States
PRO-DEX, INC.
FDA registration
PRO-DEX, INC.·9 products·🇺🇸 United States
Pro-Dex Inc
FDA registration
Pro-Dex Inc·9 products·🇺🇸 United States
DMX IMAGING, LLC
FDA registration
DMX IMAGING, LLC·1 product·🇺🇸 United States
Ventlab
FDA UDI
VENTLAB, LLC·10889483100752·1/2 LITER HYPER SYSTEM W/MANOMETER,D2 MASK AND ...
American Eagle Instruments
FDA UDI
AMERICAN EAGLE INSTRUMENTS, INC.·00841013104879·EXPL/PROBE 23/1 (YELLOW) (3/8)
DCX Disposable Cassette (DCX)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arm Monopolar hook
FDA UDI
DEX SURGICAL·03665772000091·The monopolar hook are reusable (40 uses) endos...
Monopolar protection sleeve
FDA UDI
DEX SURGICAL·03665772000046·Monopolar protection sleeve is designed to be i...
Arm Monopolar scissors
FDA UDI
DEX SURGICAL·03665772000077·The monopolar scissors are reusable (20 uses) e...