21 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377542·Integra® Jarit® Cooley Intracardiac Needle Hold...
Punch
FDA UDI
ELLIQUENCE, LLC·00846338003463·
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016517·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18m...
PATCHASSIST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECSYS CORTISOL TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929022528·CIB 12Dx12Wx18H
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929022542·Solid 12Dx12Wx18H
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 12, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 26, 2022
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 4, 2011
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023