12 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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ClearCalc Model RADCA V2
FDA 510(k)
FDA Class 2
·Radiology
MediBag
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00850000509238·MediBag 420 ml w/ Nuraxial Connector
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776150839·5mm overall diameter "L" hook electrode 33cm re...
ELMED
FDA UDI
ELMED INCORPORATED·00842180107717·5 MM DIA., 33 CM, INSULATED "L" HOOK ELECTRODE...
Bendit2.7 Steerable Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
HEATLUX
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
EVERFLO OXYGEN CONCENTRATOR
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CAW·August 6, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2011
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021