24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031516·1.6mm Modified LeFort Plate, Right, 7mm
Trivicta
FDA UDI
Ortho Development Corporation·00822409123636·Collar STD Size 11
Distal Femur Plate
FDA UDI
I.T.S. GmbH·09120047299838·Distal Femur Plate, 11-Hole, Left
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776305130·Tissue Forceps 6", 3x4 Teeth
X SERIES
FDA UDI
Zoll Medical Corporation·00847946030247·X SERIES ADVANCED, 12 LEAD W/INTERP, SPO2, SPCO...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946061012·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...
Eclipse Mini
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522130328·ECLIPSE MINI ECG SENSOR
Eclipse Mini
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522130762·ECLIPSE MINI ECG SENSOR, DEFIB SAFE
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 1, 2024
Widex
FDA UDI
Widex A/S·05706069908107·WIDEX MOMENT MRB2D DEMO (Silver Grey ) 110, Tel...
AVEA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 17, 2015
ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·October 11, 2013
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 22, 2013
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·September 30, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·June 10, 2011
LEVEL 1 HOTLINE FLUID WARMING SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·January 25, 2022
Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016