Navident

FDA 510(k)

FDA Class 2 ·Dental

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BOSS 8F Balloon Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGER

ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

FDA 510(k)

FDA Class 2 ·Cardiovascular

Thin Layer Chromatography, Morphine

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Morphine

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt

Labware, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Labware, Assisted Reproduction, 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