Med-Link Temp-pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAF Guard

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BOSS 8F Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S

Liquid Chromatography, Ethosuximide

FDA classification

FDA Class 2 ·Liquid Chromatography, Ethosuximide

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt

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