Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Europe Gateway International B.V.

Authorized representative

🇳🇱 Netherlands

BIO-TECHNE SAS

Authorized representative

🇫🇷 France·2 Manufacturers

AurisMed AS

Authorized representative

🇳🇴 Norway

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System

Fab, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fab, Fitc, Antigen, Antiserum, Control

Fab, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fab, Rhodamine, Antigen, Antiserum, Control

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Porter Silber Hydrazone, 17-Hydroxycorticosteroids

FDA classification

FDA Class 1 ·Porter Silber Hydrazone, 17-Hydroxycorticosteroids

Ceruloplasmin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ceruloplasmin, Antigen, Antiserum, Control

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·PIPLINE TM EMBOLIZATION DEVICE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device (PFED)