10,000 results · 32ms · Sources: EU EUDAMED, US FDA

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Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASOSEAL ON-SITE PRECISION CLOSURE DEVICE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·FINISHING WIRE UNIVERSAL

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY PACEMAKERS

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

FDA Pre-Market Approval
FDA Class 3 ·FLEX MOBILE BEARING KNEE

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTMATE XVE LVAS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·KELMAN(TM) OMNIFIT II MODEL 2100

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER PFO OCCLUDER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SYNERGYST II PULSE GENERATOR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV ABSORBING POST.CHAM.IOL

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·OSTEOSTIM(R)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Hybrid L24 Implant System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens (LAL), Light Delivery Device (LDD) System