POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Smart External Drain (SED) System

FDA 510(k)

FDA Class 2 ·Neurology

WEE BAG O'MERCURY

FDA 510(k)

FDA Class 2 ·Ophthalmic

BLADDERSCAN BVI 5000

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS

FDA 510(k)

FDA Class 2 ·Dental

HEART RATE VARIABILITY SOFTWARE OPTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

RS-4M

FDA 510(k)

FDA Class 2 ·Physical Medicine

ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRN THERMALCARE, MODEL 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEFIBRILLATOR LEAD ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE

FDA 510(k)

FDA Class 2 ·Anesthesiology

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

FDA 510(k)

FDA Class 2 ·Cardiovascular

Katalyst Mark 1 Muscle Stimulation System Model 2

FDA 510(k)

FDA Class 2 ·Physical Medicine

SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIEMENS Q4000

FDA 510(k)

FDA Class 2 ·Radiology

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

FDA 510(k)

FDA Class 2 ·Immunology