ZINC CEMENT

FDA 510(k)

FDA Class 2 ·Dental

COMPOSITE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

Genesys Spine 3DP AIS-C II Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Belun Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

Belun Ring BLR-100X

FDA 510(k)

FDA Class 2 ·Cardiovascular

Belun Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Belun Sleep System BLS-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LaparoGuard

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP

FDA 510(k)

FDA Class 2 ·Orthopedic

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Insulin syringe with integrated needle DL

FDA 510(k)

FDA Class 2 ·General Hospital

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

FDA 510(k)

FDA Class 2 ·Radiology

T3 RIA (PEG) DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RABBIT ANTIBODY TO HUMAN T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIIODOTHYRONINE RIA SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE FREE T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry