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

BODY FLUID BARRIER KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DURATECH HOSPITAL TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

CORVIS ST

FDA 510(k)

FDA Class 2 ·Ophthalmic

KING DIAGNOSTICS UREA NITROGEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

KING SODIUM/POTASSIUM STANDARD MODIFIED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KING DIAGNOSTICS GLUCOSE (HK) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Myopia Master

FDA 510(k)

FDA Class 2 ·Ophthalmic

KD 0.02 M CALCIUM CHLORIDE SOLUTION

FDA 510(k)

FDA Class 2 ·Hematology

KING DIAGNOSTICS CHLORIDE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pentacam AXL Wave

FDA 510(k)

FDA Class 2 ·Ophthalmic