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

FDA 510(k)

FDA Class 2 ·Dental

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GTK Disposable Needle Guides

FDA 510(k)

FDA Class 2 ·Radiology

FMT Disposable and Autoclavable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Mikron Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

uDR 780i

FDA 510(k)

FDA Class 2 ·Radiology

PleuraFlow System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMR 580, uMR 588

FDA 510(k)

FDA Class 2 ·Radiology

uDR 592h, uDR 596i

FDA 510(k)

FDA Class 2 ·Radiology

uCT ATLAS with uWS-CT-Dual Energy Analysis

FDA 510(k)

FDA Class 2 ·Radiology

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

PleuraFlow System with FlowGlide

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMR Omega with uWS-MR-MRS

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology