JAZZ System

FDA 510(k)

FDA Class 2 ·Orthopedic

Oniris

FDA 510(k)

FDA Class 2 ·Dental

JAZZ LOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

Universal Tendon Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

LIGAFIX INTERFACE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

S52D DIGITAL VIDEO LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIOFLON, CARDIOXYL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADENOVIRUS R-GENE US

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO AEQUALIS SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Parietene Macroporous Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNiD Spine Analyzer

FDA 510(k)

FDA Class 2 ·Radiology

Atalante X

FDA 510(k)

FDA Class 2 ·Physical Medicine

Parietene™ Macroporous Mesh (PPM5050 )

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CardioLogs ECG Analysis Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IDCAM Dental Implants

FDA 510(k)

FDA Class 2 ·Dental

EndoNaut

FDA 510(k)

FDA Class 2 ·Radiology

Withings Sleep Rx

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ExactechGPS Total Shoulder Application, Equinoxe Planning Software

FDA 510(k)

FDA Class 2 ·Neurology