MAGNESIUM STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URIC ACID STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

S2 Pigment Removal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Genesys Spine 3DP AIS-C II Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT

FDA 510(k)

FDA Class 2 ·Dental

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

TENZCARE SNAP ELECTRODE, NO. 6865

FDA 510(k)

FDA Class 2 ·Neurology

3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRECISE ILA AND ILAN SURGICAL STAPLES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYOCARE PLUS DUAL CHANNEL STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

TENZCARE(TM) SNAP ELECTRODE 6867

FDA 510(k)

FDA Class 2 ·Neurology

PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Radiology

DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/

FDA 510(k)

FDA Class 2 ·Hematology

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic