RAICHEM(TM) SPIA(TM) IGA REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

AMER. HISTO-ID SYS PRIMARY IGA 2720-21

FDA 510(k)

FDA Class 2 ·Immunology

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

FDA 510(k)

FDA Class 2 ·Immunology

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM

FDA 510(k)

FDA Class 2 ·Immunology

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.

FDA 510(k)

FDA Class 2 ·Immunology

ACA IMMUNOGLOBIN A TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

Stella

FDA 510(k)

FDA Class 2 ·Dental

LUNA DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PYXIS 3D Titanium Cervical Cage system

FDA 510(k)

FDA Class 2 ·Orthopedic

EvaQMax Smoke Evacuation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AnyPlus II Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MagDen Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

INNOVISION-EXII

FDA 510(k)

FDA Class 2 ·Radiology

AnyPlus Navigated Instruments System

FDA 510(k)

FDA Class 2 ·Neurology

Dyflex-II

FDA 510(k)

FDA Class 2 ·Orthopedic

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Balex bone Expander System

FDA 510(k)

FDA Class 2 ·Orthopedic

Luna Dental Implant System- Healing Abutment

FDA 510(k)

FDA Class 2 ·Dental

AUTOMATIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular