BIONIKE A/Q PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BEDSIDE CADDY

FDA 510(k)

FDA Class 2 ·General Hospital

GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

CAAS UNICOMPARMENTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ALPHATEC EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Mariner RDX System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPIRAL LOCK DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BECKMAN URINE PROTEIN CALIBRATOR (UCAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Optima Coil System (OptiBlock Line Extension)

FDA 510(k)

FDA Class 2 ·Neurology

ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE

FDA 510(k)

FDA Class 2 ·Dental

IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

VERIPATH PERIPHERAL GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

FDA 510(k)

FDA Class 2 ·General Hospital

THEROX INFUSION GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PSC-1 W/OTHER NUMERICAL

FDA 510(k)

FDA Class 2 ·Radiology