SkyOPS™ Orthopedic Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

MICRODOSE SILANE

FDA 510(k)

FDA Class 2 ·Dental

MICRODOSE DENTIN CONDITIONER

FDA 510(k)

FDA Class 2 ·Dental

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

SILENT SLEEP

FDA 510(k)

FDA Class 2 ·Dental

DISPOS-A-SCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIDEKICK POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA Pre-Market Approval

FDA Class 2 ·BAYER IMMUNO 1 SYSTEM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

NEBA SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PONTO BONE ANCHORED HEARING SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES

FDA 510(k)

FDA Class 2 ·Neurology

ORTHOREX INTRA-OPERATIVE LOAD SENSOR

FDA 510(k)

FDA Class 2 ·Neurology

BAHA CORDELLE II

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat