10,000 results · 208ms · Sources: EU EUDAMED, US FDA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DUOVISC VISCOELASTIC SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLilQ System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE HPV DNA TEST

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB (R) EIA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT, DUOVISC,DISCOVISC

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM

FDA Pre-Market Approval
MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE

Wheelchair, Stair Climbing

FDA Pre-Market Approval
FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL 3 RF CRT-D SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MASTERS SERIES VALVE: PTFE SEWING CUFF

Key

FDA registration
GN ReSound (Malaysia) Sdn Bhd.·1 product·🇲🇾 Malaysia

Key

FDA registration
GN RESOUND CHINA, LTD.·1 product·🇨🇳 China

Key

FDA registration
GN ReSound (Malaysia) Sdn. Bhd·1 product·🇲🇾 Malaysia

Key

FDA registration
GN Hearing Care Corporation·1 product·🇺🇸 United States