PENUMBRA CATHERER 025

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD MAX CT/GC/TV 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

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