Flight 60 Ventilator

FDA 510(k)

FDA Class 2 ·Anesthesiology

OSSIX BONE

FDA 510(k)

FDA Class 2 ·Dental

AFF (MARK I) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

OSSIX VOLUMAX

FDA 510(k)

FDA Class 2 ·Dental

OSSIX PLUS

FDA 510(k)

FDA Class 2 ·Dental

P-ARTIS

FDA 510(k)

FDA Class 2 ·Radiology

OSSIX Breeze

FDA 510(k)

FDA Class 2 ·Dental

ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HandPICO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KOROT Blood Pressure Monitor (KOROT P3 Accurate)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

FDA 510(k)

FDA Class 2 ·General Hospital

Plaxpot Multi Plasma

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BENCOX Mirabo Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·BONECEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·SURGICAL SIMPLEX(R) P BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·SURGICAL SIMPLEX BONE CEMENT

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 1 AND ENDURANCE BONE CEMENTS