Safety Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

THORACOSCOPE/LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAPID Web

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REBOX II (TENS)

FDA 510(k)

FDA Class 2 ·Neurology

LOOP ELECTRODE, BALL ELECTRODE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E-1 ESTHETIC COMPOSITE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TOKUYAMA SHIELD FORCE

FDA 510(k)

FDA Class 2 ·Dental

Heel Incision Safety Lancet (SteriHeel 2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RESO-PAC PERIODONTAL DRESSING

FDA 510(k)

FDA Class 2 ·Dental

EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU LIFE KEY AND AMBU RES-CUE KEY

FDA 510(k)

FDA Class 2 ·Anesthesiology

IFS PROFILE PLATES, SCREWS, AND WASHERS

FDA 510(k)

FDA Class 2 ·Orthopedic

AMBU RMT VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

FDA 510(k)

FDA Class 2 ·Hematology

IFS SUBTALAR IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471

FDA 510(k)

FDA Class 2 ·Cardiovascular