20 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KINGYIELD WRIST BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981063245·CROSSBAR, SMALL, 5.5 ROD
In-Situ Bender Left
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068585·
MANUKATEX
FDA 510(k)
FDA Unclassified
·Unknown
KINETIC CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242227·Torque Limiting Driver Size 15
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 2, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·September 23, 2014
EBI MODEL 10D
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·June 2, 2011
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 5, 2023
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
FDA Enforcement
Class II
·Terminated·Integrated Science Systems Inc·June 15, 2016
FLEXI SEAL SIGNAL (FMS)
FDA Adverse Event
Injury
·CONVATEC INC.·Product code KNT·October 11, 2016
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 11, 2020
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021