PRESSURE STOPCOCK/MANIFOLD

FDA 510(k)

FDA Class 2 ·General Hospital

AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)

FDA 510(k)

FDA Class 2 ·Neurology

SunClear Aligner system

FDA 510(k)

FDA Class 2 ·Dental

Synapse Occipital-Cervical-Thoracic (OCT) System

FDA 510(k)

FDA Class 2 ·Orthopedic

FLAME PHOTOMETER CALIBRATION STANDARDS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Orchid Safety Release Valve(TM)

FDA 510(k)

FDA Class 2 ·General Hospital

LightStim Elipsa

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SpinMedix Absorbable Fibrous Membrane

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InfuLife

FDA 510(k)

FDA Class 2 ·General Hospital

HotDog Warming Mattress + Return Electrode

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cardinal Health Non-Reinforced Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

30 ML OR 60 ML PEDI-SYRINGE FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASPIRE MAX ASPIRATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup

FDA 510(k)

FDA Class 2 ·Physical Medicine

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR