56 results · 26ms · Sources: EU EUDAMED, US FDA

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OSOM INFLUENZA A&B TEST MODEL 190

FDA 510(k)
FDA Class 1 ·Microbiology

TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NOVOSYN QUICK (SEE H11)

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 27, 2024

NOVOSYN QUICK (SEE H11)

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 27, 2024

NOVOSYN QUICK (SEE H11)

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 27, 2024

NOVOSYN QUICK (SEE H11)

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 27, 2024

NOVOSYN QUICK (SEE H11)

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 27, 2024

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 5, 2021

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·March 30, 2019

EVIS EXERA III DUODENOVIDEOSCOPE

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·February 18, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

DUO FLUID CART

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·December 21, 2017

ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·August 31, 2018

LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

TAXUS (R) LIBERTÉ (R) ATOM (TM)

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 14, 2011

ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·June 25, 2020

EVAC STATION

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·September 5, 2017

ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·January 11, 2018