DIASTAT ENA SINGLE WELL SCREEN KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-MPO (PANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-PR3 (C-ANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

ECOGEL 300 TENS GEL

FDA 510(k)

FDA Class 2 ·Neurology

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-THYROID PEROXIDASE KIT

FDA 510(k)

FDA Class 2 ·Immunology

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

VersaCross Connect Transseptal Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS

FDA 510(k)

FDA Class 2 ·Neurology

OsteoCool V-3 RF Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Mechanical Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

INDISCAL ASPIRATION DEVICE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

CARIESCAN PRO

FDA 510(k)

FDA Class 2 ·Dental

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)

FDA Class 2 ·Hematology

Epicardial Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAUNETTE, PORTABLE STEAM CABIN

FDA 510(k)

FDA Class 2 ·Physical Medicine