CORNING 965 CARBON DIOXIDE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KODAK EKTA-CHEM CLINICAL CHEM. SLIDES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAMBRO LUNDIA COIL DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REFLAB SYSTEM PACK LIQUID CO2 REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE VITA 2 DISPOSABLE DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

fixLOCK DHS Plate 4.5 mm - 125° - S.S.

Device

EU MDR · Eu Md Class 2b ·GPC Medical Limited·On the market·31 countries

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)

FDA 510(k)

FDA Class 1 ·Radiology

KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)

FDA 510(k)

FDA Class 2 ·Radiology

2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)

FDA 510(k)

FDA Class 1 ·Radiology

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S

FDA 510(k)

FDA Class 1 ·Cardiovascular

Smart Scope® CX

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP;

Body Shape

Device

EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·On the market·10 countries

Spirit Trio

Device

EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·On the market

Top Epil Classic

Device

EU MDR · Eu Md Class 1 ·Top Engineering Sarl·On the market·7 countries

Extra 818

Device

EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·On the market·15 countries

Prime 810

Device

EU MDR · Eu Md Class 1 ·Top Engineering Sarl·On the market·8 countries

Skin Shape

Device

EU MDR · Eu Md Class 1 ·Top Engineering Sarl·On the market·9 countries