18 results · 168ms · Sources: EU EUDAMED, US FDA

SHAPE-HF

FDA registration
SHAPE MEDICAL SYSTEMS, INC·1 product·🇺🇸 United States

Shape-HF DRR Testing system

FDA registration
SHAPE MEDICAL SYSTEMS, INC·1 product·🇺🇸 United States

Disposable Patient Interface with filter

FDA UDI
Shape Medical Systems, Inc.·B20044012·Disposable patient interface with filter 0004-4012

Shape-HF

FDA UDI
Shape Medical Systems, Inc.·B20044001·Disposable Patient Interface is part of the Sha...

Shape

FDA UDI
Shape Medical Systems, Inc.·B200HF012·Paramagnetic Shape analyzer Product 0012

Shape-HF

FDA UDI
Shape Medical Systems, Inc.·B20089001·Shape-HF system

Shape

FDA UDI
Shape Medical Systems, Inc.·B20040011·Shape DPI

Shape II System Refurbished

FDA UDI
Shape Medical Systems, Inc.·B2009012·Full Shape II system with paramagnetic analyzer

Shape-HF

FDA UDI
Shape Medical Systems, Inc.·B200HF001·Shape-HF analyzer

Shape Vital Sign System

FDA UDI
Shape Medical Systems, Inc.·B20083012·Full Shape II system with paramagnetic analyzer

Shape-HF Cardiopulmonary Testing System

FDA 510(k)
FDA Class 2 ·Anesthesiology

SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

MedR-AR Services B.V.

Authorized representative
🇳🇱 Netherlands·13 Manufacturers·31 Devices

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY

Vingmed AB

Importer
🇸🇪 Sweden·25 Manufacturers

Vapotherm

FDA UDI
VAPOTHERM, INC.·00841737102069·Precision Flow Bi-Annual PM Kit

Nucleus

FDA UDI
COCHLEAR LIMITED·09321502029247·FREEDOM BTE RECHARGEABLE BATTERY, BROWN

BREG

FDA UDI
BREG, INC.·00672736020678·