GC BASE W/ 1% GCHI

FDA 510(k)

FDA Class 2 ·Microbiology

MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

MARTIN-LEWIS AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

SpinMedix Absorbable Fibrous Membrane

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NY FERMENTATION MEDIA

FDA 510(k)

FDA Class 2 ·Microbiology

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM

FDA 510(k)

FDA Class 2 ·Radiology

SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE

FDA 510(k)

FDA Class 2 ·Hematology

CareEvent inclusive of the CareEvent Mobile Application accessory

FDA 510(k)

FDA Class 2 ·Cardiovascular

Grivamax Family of Lasers, Models 272 and 148

FDA 510(k)

FDA Class 2 ·Physical Medicine

CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology