9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMPOWR Revision Symmetric Knee Cones
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578877·CoRoent Ant TLIF Ti, 14x10x32mm 4°
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
FDA 510(k)
FDA Class 2
·Orthopedic
EVIS EXERA II BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEM CORP·Product code EOQ·October 30, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 20, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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