9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Health Expert Electronic Stimulator
FDA 510(k)
FDA Class 2
·Neurology
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 3, 2008
MOSAIQ
FDA Adverse Event
Malfunction
·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 24, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·August 4, 2011
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 31, 2018
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025