13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pristine Arthroscopic Visualization System
FDA 510(k)
FDA Class 2
·Orthopedic
V-Strap Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232444·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114230·LASIK CANNULA FORMS 27GA 4-PORTS
CellChek 20 rc
FDA 510(k)
FDA Class 2
·Radiology
MIRAGE FULL FACE MASK SERIES 2
FDA 510(k)
FDA Class 2
·Anesthesiology
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 16, 2011
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 12, 2013
OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·November 13, 2019
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·April 10, 2020
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
FDA Enforcement
Class II
·Ongoing·Diasorin Inc.·December 18, 2024
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013