12 results
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47ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Recall
Terminated
·Signal Medical Corporation·Product code LPH·September 23, 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 Recall
Terminated
·Signal Medical Corporation·Product code JWH·September 30, 2014
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
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
FDA Recall
Terminated
·Signal Medical Corporation·Product code GFJ·February 20, 2017
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
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 Recall
Terminated
·Ad-Tech Medical Instrument Corporation·Product code GYC·December 18, 2012
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
FDA Recall
Terminated
·Datascope Corporation·Product code DSP·February 4, 2009
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·October 15, 2012
Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis 46250.(**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJF·August 30, 2007
"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·August 30, 2010