SERACON TM SR IV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SERACON TM SR III

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PLATELET CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

SERACON-N

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SERACON CAL D025

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS

FDA 510(k)

FDA Class 2 ·Hematology

QUANTICEL-HRP

FDA 510(k)

FDA Class 2 ·Hematology

QUANTICEL HHR # L500 AND L501

FDA 510(k)

FDA Class 2 ·Hematology

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

FDA 510(k)

FDA Class 2 ·General Hospital

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

FDA 510(k)

FDA Class 2 ·General Hospital

XD

FDA 510(k)

FDA Class 2 ·Radiology

Neu Platform

FDA 510(k)

FDA Class 2 ·Neurology

CaRi-Plaque

FDA 510(k)

FDA Class 2 ·Radiology

Nissha Medical Technologies Neutral Electrodes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aline Ablation Intelligence

FDA 510(k)

FDA Class 2 ·Radiology

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE (Colors & Flavors), SKORE (Colors)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology