THERMODILUTION CARDIAC OUTPUT COMPUTER-

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 617 CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMS-2000S STRESS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

IAI PROGRAM-COMPUTER PROGRAM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MTC 6210A CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC OUTPUT COMPUTER (MODEL COC-100)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC OUTPUT OPTION 39

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHEETAH NICOM SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EK-VIEW(TM) ECG MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL SP1465 CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BATTERY OPERATED FLOW RATE COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hypotension Decision Assist Model HDA-OR2

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIDEO-DILUTION TECH. MARK I INSTRUMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vitreoretinal Cannulae (F11-B)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterimedix Ltd·1 device

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

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