AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Cryopush Cold Compression Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cold Compression Wrap Pro

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISIS MER SYSTEM/ELEKTA MER SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

FDA 510(k)

FDA Class 2 ·Neurology

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

FDA 510(k)

FDA Class 2 ·Immunology

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE ONLINE TDM PHENYTOIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AGGRO/LINK COMPUTER INTERFACE

FDA 510(k)

FDA Class 2 ·Hematology

PLATELET AGGREGOMETER

FDA 510(k)

FDA Class 2 ·Hematology

RISTOCETIN PLATELET AGGREGA-REAGENT TEST

FDA 510(k)

FDA Class 2 ·Hematology

AGGRO/LINK CONTROL SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

PLATELET AGGREGATION PROFILER #PAP-4

FDA 510(k)

FDA Class 2 ·Hematology