NADAL Malaria Pf/Pan Ag 4 Species Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·nal von minden GmbH·1 device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (3% SODIUM HYALURONATE)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM

FDA Pre-Market Approval

NIR ON RANGER AND NIR ON RANGER WITH/SOX

Diazyme Procalcitonin (PCT) Assay

FDA registration

Diazyme Laboratories, Inc.·1 product·🇺🇸 United States

Access PCT (P/N: C53987)

FDA registration

BECKMAN COULTER, INC.·1 product·🇺🇸 United States

Access PCT (P/N: C53987)

FDA registration

BECKMAN COULTER, INC.·1 product·🇺🇸 United States

STANBIO LABORATORY

FDA registration

STANBIO LABORATORY·1 product·🇺🇸 United States

TELEVISIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

B-CAD SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROTRAIN

FDA 510(k)

FDA Class 2 ·Neurology

AMT THERAPEUTIC TABLE, MODEL 748AMT

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

BONASTENT TRACHEAL / BRONCHIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery