15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Mini-ClotTriever Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·November 5, 2018
AS-10
FDA 510(k)
FDA Class 2
·Radiology
EBI AIS SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·December 24, 2019
Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·April 12, 2019
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·July 23, 2018
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·August 28, 2017
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·February 25, 2020
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 29, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 11, 2013
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·August 30, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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