Arseus Medical Group BV

Importer

🇳🇱 Netherlands·13 Manufacturers

Luméd inc.

Manufacturer

🇨🇦 Canada·1 Importer

HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SHELLGEL(TM) SODIUM HYALURONATE

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·ALCON REFORM CAPSULAR TENSION RING

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX(R) MODEL 4068 PACING LEAD

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·RELIATY/MODEL 3145 PACING SYSTEM ANALYZER

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·QCELLUS LASER

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER IOL'S

Bone Grafting Material, For Dental Bone Repair

FDA Pre-Market Approval

FDA Class 2 ·CERASORB DENTAL

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

bioMérieux SA

Authorized representative

🇫🇷 France·2 Manufacturers

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS/CRT-DS