EEG CUP ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

FREEMAN ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT

FDA 510(k)

FDA Class 2 ·Orthopedic

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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