CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01

FDA 510(k)

FDA Class 2 ·Immunology

INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEURON MAX SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEURON SELECT CATHETER SIZE 070

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

CIRCUMAURAL ADHESIVE REPLACEMENT

FDA 510(k)

FDA Class 2 ·Neurology