Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Sterilizable Handles

FDA UDI

Baxter Medical Systems GmbH + Co. KG·00887761967267·Sterilizable Camera Handle, 1 pc

Sterilizable Handles

FDA UDI

Baxter Medical Systems GmbH + Co. KG·00887761967274·Sterilizable ALC Handle, 1 pc

Sterilizable Handles

FDA UDI

Baxter Medical Systems GmbH + Co. KG·00887761967250·Sterilizable Central Handle, 1 pc

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

INFANT MANUAL RESUSCITATOR (PMR 2)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ZINC PVA

FDA 510(k)

FDA Class 1 ·Microbiology

BACTIDROP(TM) VOGES-PROSKAUER B

FDA 510(k)

FDA Class 1 ·Microbiology

AXION IV GOLDLINE SERIES

FDA 510(k)

FDA Class 2 ·Neurology

COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH

FDA 510(k)

FDA Class 1 ·General Hospital

ECONOSTAND

FDA 510(k)

FDA Class 2 ·Physical Medicine

AEROSOL INHALATION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEMOCHEK-A1C SAMPLE COLLECTION KIT

FDA 510(k)

FDA Class 2 ·Hematology

HEMOCHEK SAMPLE COLLECTION KIT

FDA 510(k)

FDA Class 2 ·Hematology

SLEEPRIGHT

FDA 510(k)

FDA Unclassified ·Unknown