RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

FDA classification

FDA Class 2 ·Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

FDA 510(k)

FDA Class 2 ·Immunology

ViVi® Toga Premium

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Codman Electrosurgical Generator, Foot Pedal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Attachment, Intermittent Mandatory Ventilation (Imv)

FDA classification

FDA Class 2 ·Attachment, Intermittent Mandatory Ventilation (Imv)

CARDIOSMART

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO SERV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Monitor, Eye Movement, Diagnostic

FDA classification

FDA Class 2 ·Monitor, Eye Movement, Diagnostic

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

FDA classification

FDA Class 2 ·System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Test, Albumin Cobalt Binding

FDA classification

FDA Class 2 ·Test, Albumin Cobalt Binding

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System