OSOM CARD HCG-URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

K.E.E. OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOA MEDICAL ELECTRONICS CA-1000

FDA 510(k)

FDA Class 2 ·Hematology

CMV IGG HUMAN SERUM CONTROLS

FDA 510(k)

FDA Class 2 ·Microbiology

BLA-800A

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRACROWN(TM) PRE-SOLDER

FDA 510(k)

FDA Class 2 ·Dental

C-REACTIVE PROTEIN ANTISERUM KIT

FDA 510(k)

FDA Class 2 ·Immunology

OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00

FDA 510(k)

FDA Class 2 ·Orthopedic

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC

FDA 510(k)

FDA Class 2 ·Ophthalmic

Carto Octaray Mapping Catheter with Trueref Technology

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

FDA 510(k)

FDA Class 2 ·Anesthesiology

EdgePro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visby Medical Respiratory Health Test

FDA 510(k)

FDA Class 2 ·Microbiology