KIMGUARD ONE-STEP Sterilization Wrap

FDA 510(k)

FDA Class 2 ·General Hospital

ACRYLIC HERBST SPLINT APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TCA 5R / 5S

FDA 510(k)

FDA Class 2 ·Radiology

HDR PROSTATE TEMPLATE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Radiology

BARNES FEMORAL LENGTHENING DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

SOLOS SINGLE USE TITANIUM TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

Huxley SANSA Home Sleep Apnea Test (1000-00)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Apollo Suture Anchor System and Titan Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

UNI-THREAD SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EUROPA Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic

BOTTLE DECANTER

FDA 510(k)

FDA Class 2 ·General Hospital

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

AMBULATORY INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

AVL 9181 ELECTROLYTE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROFOX SOFTWARE, MODEL 920M-41

FDA 510(k)

FDA Class 2 ·Cardiovascular

CS 1600 INTRAORAL CAMERA

FDA 510(k)

FDA Class 2 ·Dental

AJUST ADJUSTABLE SINGLE INCISION SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery