Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HA-IGMK AND ETI-HA-IGMK

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

FDA 510(k)

FDA Class 2 ·Orthopedic

PuraStat

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip

FDA 510(k)

FDA Class 2 ·Orthopedic

Cyclosporine Radioimmunoassay

FDA Pre-Market Approval

FDA Class 2 ·SANDIMMUNE(R) RADIOIMMUNOASSAY KIT

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

FDA classification

FDA Class 2 ·Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Airway Monitoring System

FDA classification

FDA Class 2 ·Airway Monitoring System

Ultrasound, Skin Permeation

FDA classification

FDA Class 2 ·Ultrasound, Skin Permeation

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

FDA classification

FDA Class 2 ·Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Aid, Cardiopulmonary Resuscitation

FDA classification

FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

Ultrasonic Body Composition Analyzer

FDA classification

FDA Class 2 ·Ultrasonic Body Composition Analyzer

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Filler, Bone Void, Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Alterable Compound For Cranioplasty

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Non-Alterable Compound For Cranioplasty

Camera, Ophthalmic, General-Use

FDA classification

FDA Class 2 ·Camera, Ophthalmic, General-Use