Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·PROGENSA PCA3 ASSAY

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK VISTA INTERBODY FUSION CAGE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP(TM) CERVICAL DISC

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE

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

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP CERVICAL DISC

Luana Med. B.V.

Authorized representative

🇳🇱 Netherlands·21 Manufacturers·506 Devices

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SOLOX VDD PACING LEAD

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U

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

FDA Pre-Market Approval

FDA Class 3 ·INFUSE(R) BONE GRAFT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Neuroform Atlas® Stent System