RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Codman Electrosurgical Generator, Foot Pedal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAREMIBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

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

Incubator, Neonatal

FDA classification

FDA Class 2 ·Incubator, Neonatal

Test, Albumin Cobalt Binding

FDA classification

FDA Class 2 ·Test, Albumin Cobalt Binding

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

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

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

FDA Pre-Market Approval

FDA Class 2 ·CA 125 ANTIBODY RIA