14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intense Pulsed Light Equipment
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Icon-Etch Refill
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2203850·Infiltration Concept. Resin Infiltration - Smoo...
CONTINUUM PACS
FDA 510(k)
FDA Class 2
·Radiology
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
FDA 510(k)
FDA Class 2
·Radiology
COVER SCREW
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC·Product code DZE·March 10, 2025
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 31, 2024
GLIDEWELL HT IMPLANT
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC·Product code DZE·March 19, 2025
GLIDEWELL HT IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC·Product code DZE·April 10, 2025
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 11, 2010
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022
ACRYSOF TORIC
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·October 31, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
ATLAS II VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
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