IMV MANIFOLD #M-506

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMV MANIFOLDS

FDA 510(k)

FDA Class 2 ·Anesthesiology

I.P.P.B., DIS. W/MANIFOLD/NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex lntraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric, RayOne Sph

FORMOSTAR

FDA 510(k)

FDA Class 2 ·Physical Medicine

RADIANCE V2

FDA 510(k)

FDA Class 2 ·Radiology

RADIANCE

FDA 510(k)

FDA Class 2 ·Radiology

Radiance V3

FDA 510(k)

FDA Class 2 ·Radiology

Radiance V4

FDA 510(k)

FDA Class 2 ·Radiology

Radiance V5

FDA 510(k)

FDA Class 2 ·Radiology

ACCURUN 145 CMV IgG Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 146 CMV IgM Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

Sentosa SA CMV Quantitation Controls (4x2)

Device

EU IVDD · Eu Ivd Annex 2 List B ·Vela Operations Singapore Pte. Ltd.·On the market

Sentosa SA CMV Controls Set (8x3)

Device

EU IVDD · Eu Ivd Annex 2 List B ·Vela Operations Singapore Pte. Ltd.·On the market

RapidFor™ CMV Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

BioPlex ToRC IgG Kit

FDA registration

Bio-Rad Laboratories, Inc.·3 products·🇺🇸 United States

BioPlex 2200 ToRC IgM kit

FDA registration

Bio-Rad Laboratories, Inc.·3 products·🇺🇸 United States

BioPlex2200 ToRC IgG Reagent Pack

FDA registration

BIO-RAD LABORATORIES, INC.·3 products·🇺🇸 United States

M-09M

FDA registration

IT DR. GAMBERT GMBH·1 product·🇩🇪 Germany