3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

QLT ABSOLUTE URINE-HCG PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cerebra Sleep System

FDA 510(k)

FDA Class 2 ·Neurology

Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

NON-STERILE SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Quantia IgE

FDA 510(k)

FDA Class 2 ·Immunology

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

FDA 510(k)

FDA Class 2 ·Radiology

BETTERCARE PLATFORM - ADVANCED WEB CLIENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERN FIX Sternal Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

SUREFLEX STEERABLE GUIDING SHEATH KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

AMP ALKALINE PHOSPHATASE REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SONIX ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

MANDIBULAR BONE DISTRACTOR

FDA 510(k)

FDA Class 2 ·Dental

Tulsa-Pro System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CADI, VERSION 4

FDA 510(k)

FDA Class 2 ·Radiology

AUTOVENT 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTROLYSE PLASMINOGEN SK KIT

FDA 510(k)

FDA Class 2 ·Hematology