776 results · 16ms · Sources: EU EUDAMED, US FDA

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·CERVICAL-STIM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·GELFOAM ABSORBABLE GELATIN SPONGE

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·EXOGEN Ultrasound Bone Healing System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASIST DEVICE

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval
FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SUSTAIN XL FAMILY OF PACEMAKERS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 pharmDx