Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA SR MRI

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

FDA Pre-Market Approval

FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE

Nitrosalicylate Reduction, Amylase

FDA classification

FDA Class 2 ·Nitrosalicylate Reduction, Amylase

Enzyme Immunoassay, Primidone

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Primidone

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification

FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·VISTA LORDOTIC INTERBODY FUSION CAGE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE

Separator, Automated, Blood Cell And Plasma, Therapeutic

FDA Pre-Market Approval

FDA Unclassified ·PROSORBA COLUMN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·LT-CAGE LUMBAR TAPERED FUSION DEVICE

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·PearlMatrix™ Bone Graft

MED-RAS GmbH Regulatory Affairs Service

Authorized representative

🇩🇪 Germany·18 Manufacturers·235 Devices

Test, Volatile Organic Compounds Breath Analysis

FDA classification

Test, Volatile Organic Compounds Breath Analysis

QuikScreen

FDA UDI

SYNTRON BIORESEARCH, INC.·00748349000342·