Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ADAPPTE ARTIFICIAL TEAR

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MIC TEST PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MIC TEST PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MIC TEST PANELS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ADAPPTE ARTIFICIAL TEAR

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification

FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification

FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

REPLICA TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ZQUIET MOUTHPIECE

FDA 510(k)

FDA Class 2 ·Dental

IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED

FDA 510(k)

FDA Class 2 ·Orthopedic

NUOVOCATH

FDA 510(k)

FDA Class 2 ·General Hospital

DELFIA(TM) FERRITIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

VIRGO (R) CMV-IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500

FDA 510(k)

FDA Class 2 ·Neurology

ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SELECTRON HDR REMOTE AFTERLOADER

FDA 510(k)

FDA Class 2 ·Radiology

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry