28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·September 22, 2025
Premium Tray
FDA UDI
Denplus Inc·D8451121314·Cold-cured acrylic resin, Pink, 11.3 kg
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032140·WFL HCA STD BASIN 1
Z Liquid HT A1-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121314·Dental porcelain/ceramic restoration kit
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016583·Mayo-Hegar NH, 14"
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016593·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14m...
SCEPTRE-VS
FDA 510(k)
FDA Class 2
·Radiology
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024
ADVANIX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·September 22, 2014
UNKNOWN DEPUY ASR 50 CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·October 30, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016