CSX-30 Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

EXTRAFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21

FDA 510(k)

FDA Class 2 ·Radiology

Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm-type Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Forehead Thermometer, Model BSX976

FDA 510(k)

FDA Class 2 ·General Hospital

OPTYSE OPHTHALMOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUEX ED; QUEX S

FDA 510(k)

FDA Class 2 ·Neurology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Artus CMV RGQ and QS-RGQ MDx Kit

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

FDA 510(k)

FDA Class 2 ·Dental

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

FDA 510(k)

FDA Class 2 ·Orthopedic

Arthrex iBalance Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAKO SURGICAL UNICONDYLAR KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

STELKAST UNICONDYLAR KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic