KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KBL Sunlamp Products (= Device Bundling name)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

T-METER

FDA 510(k)

FDA Class 2 ·Neurology

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

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

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

DURATECH HOSPITAL TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IIF-APCA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA PARIETAL CELL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Exablate Prostate System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMART WAVE GS100

FDA 510(k)

FDA Class 2 ·Physical Medicine

MDX 2000, DIGITAL ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·OMNISCEPT(TM) KB SYSTEM

K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

FDA 510(k)

FDA Class 2 ·Hematology