COBAS INTEGRA AMIKACIN MAB

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBAS-FP REAGENTS AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMIKACIN KIT (FPIA)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFIED L.J.'S SEX HELPER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODYSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

MAX-IF1000

FDA 510(k)

FDA Class 2 ·Neurology

FLUORCANASITE DENTAL CERAMIC

FDA 510(k)

FDA Class 2 ·Dental

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

VIVOSORB SHEET, MODEL FS01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REUSABLE STIMULATING ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUTMAN STABILIZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR, MODELS ND04, ND05

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DTX-100 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

NEUROLAC NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat