RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX

FDA 510(k)

FDA Class 2 ·Radiology

CYTOMEGALOVIRUS ANTIBODY SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

MET-ETCH

FDA 510(k)

FDA Class 2 ·Dental

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUELL DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

COBAS INTEGRA AMIKACIN MAB

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROTECTRODE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MRI NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357

FDA 510(k)

FDA Class 2 ·Hematology

DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL

FDA 510(k)

FDA Class 2 ·Cardiovascular

SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALL SILICONE INTERMITTENT CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A

FDA 510(k)

FDA Class 2 ·Radiology

VECTRA PRO MODELS 2 AND 4

FDA 510(k)

FDA Class 2 ·Neurology

LIDO(TM) WORKSET

FDA 510(k)

FDA Class 2 ·Physical Medicine

MARK 4 LIQUID OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACE AIM TTC FUSION NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic