WHITE KNIGHT BOVIE CORD/SUCTION TUBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REAGENT, T-3 UPTAKE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SILICONE ELASTOMER COATED LATEX FOLEY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTERAL & NASOGASTRIC SOL. ADMIN. SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHO. TRAX MODEL 4000 WHOLE BODY SCAN.

FDA 510(k)

FDA Class 2 ·Radiology

DIGOXIN RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BATTERY PACKS (VARIOUS MODELS)

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION

HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN

APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN

VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

REAADS IGM ANTI-B2GP1 TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.

FDA 510(k)

FDA Class 2 ·Immunology

BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.

FDA 510(k)

FDA Class 2 ·Immunology

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

FDA 510(k)

FDA Class 2 ·Immunology

ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

FDA 510(k)

FDA Class 2 ·Immunology