QUANTA FLASH (TM) DGP SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT

FDA 510(k)

FDA Class 2 ·Immunology

NEUROPACE BURR HOLE COVER

FDA 510(k)

FDA Class 2 ·Neurology

IMX HOMOCYSTEINE

FDA 510(k)

FDA Class 2 ·Immunology

DRI Ecstasy Plus Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ATAL-8

FDA 510(k)

FDA Class 2 ·Radiology

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

FDA 510(k)

FDA Class 2 ·Microbiology

ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUMP-JECT SYRINGE WITH LUER-LOCK

FDA 510(k)

FDA Class 2 ·General Hospital

TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16

FDA 510(k)

FDA Class 2 ·Dental

ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS

FDA 510(k)

FDA Class 2 ·Radiology

Altaviz Needle Kit

FDA 510(k)

FDA Class 2 ·General Hospital

ClotTriever XL Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

RETINAL TAAK

FDA 510(k)

FDA Class 2 ·Ophthalmic

SCIg60 Infuser, Infuset

FDA 510(k)

FDA Class 2 ·General Hospital

ZONARE ULTRA ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.

FDA 510(k)

FDA Class 2 ·Physical Medicine