ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

Vario-Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

Vibrator For Climax Control Of Premature Ejaculation

FDA classification

FDA Class 2 ·Vibrator For Climax Control Of Premature Ejaculation

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·AIA PACK PA

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

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 FT4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK BMG

FDA 510(k)

FDA Class 2 ·Immunology

AIA-PACK T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

FDA 510(k)

FDA Class 2 ·Cardiovascular