164 results · 20ms · Sources: EU EUDAMED, US FDA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·CardioMessenger Smart 4G LTE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DataBridge 4G/LTE Adapter

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

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

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE+, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMI LIES OF CRT-D DEVICES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC PROSTHESIS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN (TM) CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN Cervical Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·BRYAN CERVICAL DISC

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Stimulator, Invasive Bone Growth

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

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER