10,000 results · 28ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MMT-7002 & MMT-7003 GLUCOSE SENSORS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3037A FUNCTION PACK

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas 4800 HPV Test

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·META DDD MODEL 1230 PACER

Contrast Media, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·TRIVISC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC BIOPROSTHESIS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE ICD SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS