RAPHAEL COLOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

FDA 510(k)

FDA Class 2 ·Neurology

HEALIX ADVANCE SP PEEK Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

AxSOS 3Ti

FDA 510(k)

FDA Class 2 ·Orthopedic

Medacta Shoulder System: Threaded Glenoid Baseplate

FDA 510(k)

FDA Class 2 ·Orthopedic

One Step Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDELA SWING BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NextAR™ TKA Platform My Knee PPS

FDA 510(k)

FDA Class 2 ·Neurology

BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL

FDA 510(k)

FDA Class 2 ·Dental

G21 Cement, VADER® Pedicle System

FDA 510(k)

FDA Class 2 ·Orthopedic

PEKKTON IVORY

FDA 510(k)

FDA Class 2 ·Dental

GII Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MOTO Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments

FDA 510(k)

FDA Class 2 ·Dental

CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

NextAR™ TSA Platform

FDA 510(k)

FDA Class 2 ·Neurology

BI-FLEX URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SmartCardia 7L Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONEFIT HOLLOW CYLINDER IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

Quadra P

FDA 510(k)

FDA Class 2 ·Orthopedic