TAKE 1

FDA 510(k)

FDA Class 2 ·Dental

HORUS LASER KERATOME

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Crystal ®; Mosaic ®; Vertu ®

FDA 510(k)

FDA Class 2 ·Orthopedic

Trak Male Fertility Testing System

FDA 510(k)

FDA Class 2 ·Hematology

ClotTriever Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENTNET; CENTRAL MONITORING STATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDITEC LINK

FDA 510(k)

FDA Class 2 ·Ophthalmic

VISIRASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COAT-A-COUNT METHADONE TKMD1

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CYTOCARE LASER CATHETER FOR UROLOGY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEAR NVM-1

FDA 510(k)

FDA Class 2 ·Anesthesiology

BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV

FDA 510(k)

FDA Class 2 ·Neurology

LACERATION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

VISTA FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARGELOY PARTIAL (NON-PRECIOUS)

FDA 510(k)

FDA Class 2 ·Dental

ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109

FDA 510(k)

FDA Class 2 ·General Hospital

S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

NEOPLANT IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental