System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Cystic Fibrosis 39 Kit v2

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

GYMFORM ABS & CORE

FDA 510(k)

FDA Class 2 ·Physical Medicine

TRILUX, Z-TONE, ACRY ROCK

FDA 510(k)

FDA Class 2 ·Dental

Gymform Total ABS

FDA 510(k)

FDA Class 2 ·Physical Medicine

(MULTIPLE) DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Premium Plus Disposable Barrier Sleeve

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Premium Plus C01/C02 LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA