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