STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT

FDA 510(k)

FDA Class 2 ·General Hospital

AMICAS VISION SERIES PACS, MODEL 4.3

FDA 510(k)

FDA Class 2 ·Radiology

AMICAS PACS, VERSION 6.0

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML

FDA 510(k)

FDA Class 2 ·General Hospital

BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

EXSUDEX WOUND DRAINAGE PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Finapres Nova Noninvasive Hemodynamic Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

ARTISAN AESTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,

FDA 510(k)

FDA Class 2 ·General Hospital

Anti-Jcv Antibody Detection Assay

FDA classification

FDA Class 2 ·Anti-Jcv Antibody Detection Assay

Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Endoscopic Magnetic Retriever, Exempt

FDA classification

FDA Class 2 ·Endoscopic Magnetic Retriever, Exempt