12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Promisemed X-Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
CUSTOM SOUND SUITE 3.0 US ENGLISH
FDA UDI
COCHLEAR LIMITED·09321502018906·CUSTOM SOUND SUITE 3.0 US ENGLISH
BBL™ CultureSwab™
FDA UDI
COPAN ITALIA SPA·38053326001940·CultureSwab Amies
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·July 2, 2020
MANTARAY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2025
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 15, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 3, 2014
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
BD MICROLANCE ¿ 3 NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 16, 2022
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023