4 results
·
55ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·October 29, 2014
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·October 29, 2014
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·April 26, 2017
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
FDA Enforcement
Class I
·Terminated·Ad-Tech Medical Instrument Corporation·March 13, 2013