Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Thin Layer Chromatography, Cocaine

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Cocaine

ABDOMINAL WALL RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP

FDA 510(k)

FDA Class 2 ·Orthopedic

TUBING SET W/ IRRIGATION & ASPIRATION VALVING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DESKREM-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

FDA 510(k)

FDA Class 2 ·Orthopedic

PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOLOC SPS Shoulder Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

AGILIS ES STEERABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOPOLAR COAGULATING POLYPECTOMY SNARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular