ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

FDA 510(k)

FDA Class 2 ·Dental

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental

PRETTAU ANTERIOR T0

FDA 510(k)

FDA Class 2 ·Dental

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

FDA 510(k)

FDA Class 2 ·Dental

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Implance Dental Implant System, Implance Dental Abutment System

FDA 510(k)

FDA Class 2 ·Dental

HEARTSTART 2000, MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIR-CUSHION TOCOTONOMETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FETASCAN 1500

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FIRST MEDIC MODEL 610P

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LumenaTM Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology