ALGINATE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

DENTAL VARNISH

FDA 510(k)

FDA Class 2 ·Dental

ZINC CEMENT

FDA 510(k)

FDA Class 2 ·Dental

COMPOSITE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

Genesys Spine 3DP Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine 3DP Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine 3DP Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Digiscan FDX

FDA 510(k)

FDA Class 2 ·Radiology

Cardiovascular Angiography System

FDA 510(k)

FDA Class 2 ·Radiology

DigiX FDX

FDA 510(k)

FDA Class 2 ·Radiology

Wireless/Wired X-Ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

STARLIGHT, MODEL PD9012

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

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

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

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA

T3 RIA (PEG) DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology