16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fogarty Thru-Lumen Embolectomy Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776181802·BRUNS CURETTE STR OVAL SIZE
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187165·Integra® Jarit® Bruns Oval Cup Curette, 8", Str...
TECOTHERM NEO (T NEO)
FDA 510(k)
FDA Class 2
·Cardiovascular
CANNON II PLUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Widex
FDA UDI
Widex A/S·05706069827736·WIDEX EVOKE EBB3D (Mediterranean turquise ) 440...
Trilogy®
FDA UDI
Zimmer, Inc.·00889024119475·
Widex
FDA UDI
Widex A/S·05706069914917·WIDEX MOMENT MRB2D (Mediterranean turquise ) 44...
Widex
FDA UDI
Widex A/S·05706069692044·Widex BEYOND B-F2 (Mediterranean turquise ) 440...
MERIDIAN FILTER SYSTEM - JUGULAR
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 31, 2014
FOLFUSOR LV5
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·November 24, 2008
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2013
INSYTE AUTOGUARD PNK 20GA X 1.16IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·March 15, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013