12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465470·SCREW 7191845 MULTI-AXIAL HA COATED
Axcess Percutaneous Introducer
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333206940·Axcess Percutaneous Introducer with Multi-Purpo...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741918450·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674191845060·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543658·45mm Cervical Tooth Blade, Wide
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
THE ESPINER SAC OR E SAC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 1, 2008
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MED DEVICES GROUP·Product code FRN·July 29, 2011
UNKNOWN M2A MAGNUM HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024