POLY STAT HCG DIPSTICK TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BTA STAT TEST PRESCRIPTION HOME USE

FDA 510(k)

FDA Class 2 ·Immunology

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY

FDA 510(k)

FDA Class 2 ·Cardiovascular

O BUTMENT HB

FDA 510(k)

FDA Class 2 ·Dental

IMMEDIATE STABILIZING DEVICE (ISD)

FDA 510(k)

FDA Class 2 ·Dental

ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART-EP

FDA 510(k)

FDA Class 2 ·Neurology

OCO DENTAL IMPLANT (5.0MM DIAMETER)

FDA 510(k)

FDA Class 2 ·Dental

O BUTMENT

FDA 510(k)

FDA Class 2 ·Dental

Giraffe OmniBed Carestation CS1

FDA 510(k)

FDA Class 2 ·General Hospital

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

POLYSMITH SLEEP SYSTEM, MODEL NTI5498

FDA 510(k)

FDA Class 2 ·Neurology

BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUKUDA DENSHI MODEL FF SONIC UF-750XT

FDA 510(k)

FDA Class 2 ·Radiology

FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular