SUNCAST-D

FDA 510(k)

FDA Class 2 ·Dental

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Eon Aligner

FDA 510(k)

FDA Class 2 ·Dental

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYRTINA SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·Radiology

Neuro Omega System, NeuroSmart System

FDA 510(k)

FDA Class 2 ·Neurology

Neuro Omega System; NeuroSmart System

FDA 510(k)

FDA Class 2 ·Neurology

C50 and C80 Multi-parameter Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

039 Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Immunology

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01

FDA 510(k)

FDA Class 2 ·Immunology