11 results
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22ms
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Sources: EU EUDAMED, US FDA
3D MAC Titanium Cranial Plate (TCP) System
FDA 510(k)
FDA Class 2
·Neurology
SpheRx
FDA UDI
Nuvasive, Inc.·00887517454607·SpheRx II Washer, Large
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011253116200·ceraMotion® Lf Dentin Modifier Fluo yellow, 20 ...
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981042189·31x24mm Trial Rasp 16mm 15 deg
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
SensorX
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
WALLSTENT RX BILIARY ENDOPROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2008
UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
ENDOVIVE® SAFETY PEG KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 29, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014