8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SANDHILL ELECTRONIC CALIPER
FDA 510(k)
FDA Class 1
·Radiology
VARIOUS AFTERLOADING APPLICATORS
FDA 510(k)
FDA Class 1
·Radiology
BD BBL¿ MGIT¿ OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·May 13, 2024
INSYNC MAXIMO
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·February 11, 2013
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 16, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024