SILENT PARTNER MODEL 10-1001

FDA 510(k)

FDA Class 2 ·Anesthesiology

VISUWELL(R) REAGIN TEST (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Microbiology

SYNERMED GLUCOSE REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MyHip Planner & Verifier

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Zeramex P6 Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Straumann BLX Ø3.5 mm Implants

FDA 510(k)

FDA Class 2 ·Dental

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

FDA 510(k)

FDA Class 2 ·Orthopedic

MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)

FDA 510(k)

FDA Class 2 ·Orthopedic

Myocardial Strain Software Application

FDA 510(k)

FDA Class 2 ·Radiology

MindMotion(TM) GO

FDA 510(k)

FDA Class 2 ·Physical Medicine

M.U.S.T. MINI Posterior Cervical Screws System

FDA 510(k)

FDA Class 2 ·Orthopedic

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

DePuy Synthes Femoral Neck System

FDA 510(k)

FDA Class 2 ·Orthopedic

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

FDA 510(k)

FDA Class 2 ·Orthopedic

Easi-Vue® embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BrightMatter Guide with BrightMatter Pointer

FDA 510(k)

FDA Class 2 ·Neurology