INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

U-CLIP DEVICE, MODELS B140, B160 AND B180

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

U-CLIP UNI-FIRE, MODEL M65

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMPLATZER RELIANT CATHETER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

U-CLIP DEVICE, MODEL NC65

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Purzir Dental Zirconia

FDA 510(k)

FDA Class 2 ·Dental

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)

FDA 510(k)

FDA Class 2 ·Neurology

Air Compression Therapy Device, model HW6007

FDA 510(k)

FDA Class 2 ·Physical Medicine

AUTORANGING DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

AUTORANGING DIGITAL CLINICAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ACS CORONARY GUIDING

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology