Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT

breastscape v1.0

FDA 510(k)

FDA Class 2 ·Radiology

Cefaly

FDA 510(k)

FDA Class 2 ·Neurology

Functional MR V1.0

FDA 510(k)

FDA Class 2 ·Radiology

MR Diffusion Perfusion Mismatch V1.0

FDA 510(k)

FDA Class 2 ·Radiology

CT Perfusion V1.0

FDA 510(k)

FDA Class 2 ·Radiology

MR DWI/FLAIR Measurement V1.0

FDA 510(k)

FDA Class 2 ·Radiology

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

FDA 510(k)

FDA Class 2 ·Orthopedic

Olea S.I.A. Neurovascular V1.0

FDA 510(k)

FDA Class 2 ·Radiology

QUIES SAS

Importer

🇫🇷 France

ILUMARK GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers·1 Device

CINA-VCF

FDA 510(k)

FDA Class 2 ·Radiology

CINA-ASPECTS

FDA 510(k)

FDA Class 2 ·Radiology

CINA-iPE

FDA 510(k)

FDA Class 2 ·Radiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SAHARA CLINICAL BONE SONOMETER

Piezosurgery Flex

FDA registration

Mectron North America·5 products·🇺🇸 United States

Synergy Health Daniken AG

FDA registration

Synergy Health Daniken AG·5 products·🇨🇭 Switzerland