ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

Vario-Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

THE BIBICURE SYS BREAST TONER

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

THE BIBICURE SYS DERMEPIL NATURAL HAIR

FDA 510(k)

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

FDA 510(k)

FDA Class 2 ·Orthopedic

SP-CL Hip Stem and LCU Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

PROLONG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

FDA 510(k)

FDA Class 2 ·Dental

TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)

FDA 510(k)

FDA Class 2 ·General Hospital

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)

FDA Class 2 ·Immunology

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK HGH

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AIA-PACK FT4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK IRI

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AIA-PACK BMG

FDA 510(k)

FDA Class 2 ·Immunology