FIBRINOTEST(TM) - FIBRINOGEN ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

DIGOXIN FPIA REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

JEDMED LARYNGEAL SCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765

FDA 510(k)

FDA Class 2 ·Hematology

NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

CONCORD 88

FDA 510(k)

FDA Class 2 ·Dental

DynaFlex

FDA 510(k)

FDA Class 2 ·Dental

ASEP PLUS SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

RLN NERVE LOCATOR/MONITOR; MODEL A

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 AST-YS FLUCONAZOLE

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

STERILE/SINGLE USE EYE SPHERE IMPLANTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

SOLOBOND M

FDA 510(k)

FDA Class 2 ·Dental

MONOJECT PHARMACY TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MULTI-FLEX TABLE--MODEL 200

FDA 510(k)

FDA Class 2 ·Physical Medicine