CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)

FDA Class 2 ·Immunology

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)

FDA Class 2 ·Immunology

Cytokeratin Fragments 21-1 Eia Kit

FDA classification

FDA Class 2 ·Cytokeratin Fragments 21-1 Eia Kit

AVK CONTROL I & II

FDA 510(k)

FDA Class 2 ·Hematology

BI-O.K. STEAM TEST-PAK

FDA 510(k)

FDA Class 2 ·General Hospital

BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)

FDA 510(k)

FDA Class 2 ·General Hospital

Endoform Reconstructive Template - PLGA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Endoform Dental Membrane

FDA 510(k)

FDA Class 2 ·Dental

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

FDA 510(k)

FDA Class 2 ·Radiology

Climax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VENA CAVA FILTER SYSTEMS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

MATRIXBRUSH ENDOMETRIAL SAMPLER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ATHENA PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OAK RIDGE PRODUCTS SHARP CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

FIREFLY® Midline Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

Oak Ridge Products Sharps Containers

FDA 510(k)

FDA Class 2 ·General Hospital