613 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS B 221 <6> SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHL·March 30, 2026
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Oxyhemoglobin
FDA classification
FDA Class 2
·Oxyhemoglobin
GMZ ASSOCIATES, LTD.
FDA registration
GMZ ASSOCIATES, LTD.·1 product·🇺🇸 United States
TECNO-GAZ S.P.A.
FDA registration
TECNO-GAZ S.P.A.·1 product·🇮🇹 Italy
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·July 7, 2020
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112263·
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112423·
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112300·
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112348·
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112225·
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112188·
Midmark
FDA UDI
MIDMARK CORPORATION·00841709112386·
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
FDA 510(k)
FDA Class 2
·General Hospital
CNS
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 25, 2019
Anti-HSV gG-2 IgG
FDA UDI
ZEUS SCIENTIFIC, INC.·00845533003230·The Anti-HSV gG-2 IgG is intended for the quali...
Anti-HSV gG-2 IgG
FDA UDI
ZEUS SCIENTIFIC, INC.·00845533003223·The Anti-HSV gG-2 IgG is intended for the quali...
Anti-HSV gG-1 IgG
FDA UDI
ZEUS SCIENTIFIC, INC.·00845533003209·The Anti-HSV gG-1 IgG is intended for the quali...
Anti-HSV gG-1 IgG
FDA UDI
ZEUS SCIENTIFIC, INC.·00845533003216·The Anti-HSV gG-1 IgG is intended for the quali...
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology