SURE-CUT

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

KCK INDUSTRIES' SURGICAL INSTRUMENTS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

EUROTROL GAS-ISE METABOLITES

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CueSee Hypoxic

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PARALLAX EZFLOW CEMENT DELIVERY SYSTEM

FDA 510(k)

FDA Class 1 ·Orthopedic

EMIT URINE METHADONE ASSAY #3E319

FDA 510(k)

FDA Class 1 ·Immunology

COAT-A-COUNT MORPHINE KIT & COMPONENTS

FDA 510(k)

FDA Class 1 ·Immunology

TENONE(TM) OPIATES CATALOG: VKSO1,4

FDA 510(k)

FDA Class 1 ·Immunology

CT/MRI TOPOGRAPHIC MARKER

FDA 510(k)

FDA Class 1 ·Radiology

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VALTRAC PURSESTING DEVICE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MANIPLER DISPOSABLE SKIN STAPLER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VALTRAC (BAR) REMOVER DEVICE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GOGGLE SAFEGUARD

FDA 510(k)

FDA Class 1 ·Ophthalmic

NON-PRESCRIPTION SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

CONTROLLED PASSIVE MOTION MACHINE

FDA 510(k)

FDA Class 1 ·Physical Medicine

COULTER MULTI Q PREP

FDA 510(k)

FDA Class 1 ·Hematology

Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)

FDA 510(k)

FDA Class 1 ·Physical Medicine