15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013
BRIDGE III RECEIVER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO MARSPO2, MODEL 2001
FDA 510(k)
FDA Class 2
·Cardiovascular
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 10, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·April 1, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
CONTROLLER ECLC ECLIPSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014
IPC® HANDPIECE - STYLUS TOUCH®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018