Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S)

HOMECHECK MULTIPLE DRUG CUP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DRX9000C-SL Cervical Spinal Decompression System

FDA 510(k)

FDA Class 2 ·Physical Medicine

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T

FDA 510(k)

FDA Class 2 ·Hematology

FOR SURE ONE STEP BUPRENORPHINE TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID ONE STEP BUPRENORPHINE TEST CARD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GLUCOSE PILOT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

CIRCUMAURAL ADHESIVE REPLACEMENT

FDA 510(k)

FDA Class 2 ·Neurology

ARTHROTAP

FDA 510(k)

FDA Class 2 ·General Hospital

TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

FDA 510(k)

FDA Class 2 ·Orthopedic

SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology