AmniSure ROM Test Positive and Negative Controls Pack

FDA registration

QIAGEN·2 products·🇺🇸 United States

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

K030840 CD HORIZON® Spinal System

FDA registration

Sterigenics US, LLC·4 products·🇺🇸 United States

Velvet Etch

FDA registration

INTER-MED, INC.·1 product·🇺🇸 United States

Iridex Corporation

FDA registration

Iridex Corporation·1 product·🇺🇸 United States

DRI Cotinine Assay

FDA registration

Microgenics Corporation·2 products·🇺🇸 United States

TriniCAL Reference Plasma

FDA registration

TCOAG IRELAND LIMITED·1 product·🇮🇪 Ireland

SOFTFORM FACIAL IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GE ADVANCE NXI PET SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Widex

FDA UDI

Widex A/S·05706069647280·COMPASS GPS V2.2, USB plug

Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA classification

FDA Class 1 ·Single (Specified) Analyte Controls (Assayed And Unassayed)

Mesh, Surgical, Polymeric

FDA classification

FDA Class 2 ·Mesh, Surgical, Polymeric

System, Tomography, Computed, Emission

FDA classification

FDA Class 2 ·System, Tomography, Computed, Emission