19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
FDA 510(k)
FDA Class 2
·Hematology
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010091017·8 MM CANNULATED DRILL BIT
Smith and Nephew
FDA UDI
Provision·00810041631541·
Smith and Nephew
FDA UDI
Provision·B504OM0135440·
Phantom® Fibula Nail System
FDA UDI
Paragon 28, Inc.·00889795134219·3.5mm x 44mm, Threaded Peg, Ti
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512494·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512524·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512500·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512517·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512487·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033512531·
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
FDA 510(k)
FDA Class 2
·Dental
HADGEL, 4 GRAM/SYRINGE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·March 20, 2013
OVATIO
FDA Adverse Event
Malfunction
·SORIN CRM S.A.S.·Product code MRM·March 10, 2011
INSYNC II MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·March 10, 2008
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·March 27, 2024