SIGNA Premier

FDA 510(k)

FDA Class 2 ·Radiology

SafeSept Needle Free Transseptal Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

DRX9000C-SL Cervical Spinal Decompression System

FDA 510(k)

FDA Class 2 ·Physical Medicine

YOUNG PROPHY SYSTEM, PS UNIT

FDA 510(k)

FDA Class 2 ·Dental

Optima Coil System

FDA 510(k)

FDA Class 2 ·Neurology

DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

TSI Transseptal Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOFIX SCREW

FDA 510(k)

FDA Class 2 ·Dental

Synermed ISE Reagents

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

iBond Universal & iBond Ceramic Primer

FDA 510(k)

FDA Class 2 ·Dental

TransLoc 3D

FDA 510(k)

FDA Class 2 ·Orthopedic

SafeSept Transseptal Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

VixWin Platinum

FDA 510(k)

FDA Class 2 ·Radiology

Secure Wear USA Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TSN Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)

FDA 510(k)

FDA Class 2 ·Orthopedic

AIR Recon DL

FDA 510(k)

FDA Class 2 ·Radiology

SOLACE Sacroiliac Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic