Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY DUAL 8 ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787

FBI Medizintechnik GmbH

Importer

🇩🇪 Germany·1 Manufacturer

ABI SOLUTIONS SRL

Importer

🇷🇴 Romania·1 Manufacturer

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THxID BRAF assay kit

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK(R) BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOSTIM(R)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOSTIM(R)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIO OSTEOGEN SYSTEM 204