SPQ TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A)/DADE DEMENSION

FDA 510(k)

FDA Class 2 ·Immunology

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B

FDA 510(k)

FDA Class 2 ·Immunology

UC IMU B

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIA LA(A)

FDA 510(k)

FDA Class 2 ·Immunology

Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Lipoprotein, Low-Density, Antigen, Antiserum, Control

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COLORADO NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HRVWatch-Mini Wrist Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Citregen Tendon Interference Screw and Citrelock

FDA 510(k)

FDA Class 2 ·Orthopedic

STELLITE COBALT/CHROMIUM BASE METAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

SPINE ALIGN

FDA 510(k)

FDA Class 2 ·Orthopedic

AL-40

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPY-50

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-RAY ASSIST BAR

FDA 510(k)

FDA Class 2 ·Radiology

POLYLASE LP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILITATION CARTHETERS

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology