SOLITAIRE FR REVASCULARIZATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ToeTac™ 10° Hammertoe Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

12F Tri-Flow Triple Lumen Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REVOLUTION FULLFACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Game Ready GRPro 2.1 System

FDA 510(k)

FDA Class 2 ·Physical Medicine

DSM Biomedical Dental Bone Graft

FDA 510(k)

FDA Class 2 ·Dental

BRACHYTHERAPY SOURCE DEVICE, MODEL 9011

FDA 510(k)

FDA Class 2 ·Radiology

Climax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Triathlon Total KneeSystem

FDA 510(k)

FDA Class 2 ·Orthopedic

Intimate Rose Kegel Exercise System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Triathlon® Hinge Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

UHR Bipolar Implants, Restoration GAP II Implants

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRYKER PATIENT SPECIFIC POLYMER IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CDC ZIRCONIA BLANKS

FDA 510(k)

FDA Class 2 ·Dental

AXSOS DISTAL LATERAL FEMUR TS LONG PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Stryker Orthopaedics Hip Systems Labeling Update

FDA 510(k)

FDA Class 2 ·Orthopedic

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

FDA 510(k)

FDA Class 2 ·Orthopedic

Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System

FDA 510(k)

FDA Class 2 ·Orthopedic