RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES

FDA 510(k)

FDA Class 2 ·Orthopedic

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

FDA 510(k)

FDA Class 2 ·Dental

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR LSD TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STC DIAGNOSTICS LSD MICRO-PLATE EIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA DAU LSD ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

Hemo Control (optional Add Pack Hemo Control DM)

FDA 510(k)

FDA Class 2 ·Hematology

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS