28 results · 25ms · Sources: EU EUDAMED, 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