Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VOYAGER OTW CORONARY DILATATION CATHETER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VOYAGER OTW CORONARY DILATATION CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

APPLIMED-O2 1000

Basic UDI-DI

EU MDD · Eu Md Class 2b ·HELKUEB OHG·1 device

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)

FDA 510(k)

FDA Class 1 ·Immunology

CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TURBOX FIBRINOGEN

FDA 510(k)

FDA Class 2 ·Hematology

IMMUNOGLOBULINS G

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW STREP A

FDA 510(k)

FDA Class 1 ·Microbiology

SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)

FDA 510(k)

FDA Class 2 ·Dental

TURBOX

FDA 510(k)

FDA Class 1 ·Immunology

Y-MIC

FDA 510(k)

FDA Class 2 ·Dental

STAPHYTECT-OD

FDA 510(k)

FDA Class 1 ·Microbiology

CLEARPLAN

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APOLIPOPROTEIN A1

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AW-100

FDA 510(k)

FDA Class 2 ·Dental