10,000 results · 48ms · Sources: EU EUDAMED, US FDA

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Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA ANTERIOR CHAMBER INTRAOCULAR LENS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·HCS HPV, HCII HPV

FDA Pre-Market Approval
NIR PREMOUNTED STENT DELIVERY SYSTEMS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·BOSTON SCIENTIFIC SCIMED PTCA CATHETERS

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CARELINK MONITORS, MODELS 2490G AND 2490J

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MAGIC WALLSTENT ENDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·INAMED SILICONE-FILLED BREAST IMPLANTS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EP TECH EPT-1000XP RF ABLATION SYSTEM

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·VYSIS PATH VYSION HER-2 DNA PROBE KIT

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·RAPTORRAIL PTCA DILATATION CATHETER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·AMVISC/AMVISC PLUS SODIUM HYALURONATE