ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

OpenTex

FDA 510(k)

FDA Class 2 ·Dental

Rainbow LS Pressing

FDA 510(k)

FDA Class 2 ·Dental

POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANAX™ OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCESS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

0909FCB, 1212FCA

FDA 510(k)

FDA Class 2 ·Radiology

EConsole1

FDA 510(k)

FDA Class 2 ·Radiology

PAX-500

FDA 510(k)

FDA Class 2 ·Radiology

THE Graft Collagen

FDA 510(k)

FDA Class 2 ·Dental

OTOMIMIX

FDA 510(k)

FDA Class 2 ·Dental

ANYRAY PORTABLE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VIVAWAVE MICROWAVE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMT Platinum Depthalon Depth Electrode

FDA 510(k)

FDA Class 2 ·Neurology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);

FDA 510(k)

FDA Class 2 ·Radiology

SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC

FDA 510(k)

FDA Class 2 ·Radiology

Green X 18(Model : PHT-75CHS)

FDA 510(k)

FDA Class 2 ·Radiology

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Triton™ Sacroiliac Joint Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic