Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmoLED (v. 2-USA)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PIEZOSURGERY 3; OSSTEM PIEZO

FDA 510(k)

FDA Class 2 ·Dental

SMR Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

FDA 510(k)

FDA Class 2 ·Dental

PIEZOSURGERY

FDA 510(k)

FDA Class 2 ·Dental

Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRECISION RXI ANALOG X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

THD Anopress with THD SensyProbe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TEETHAN 2.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

MIROXI

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISKOM

FDA 510(k)

FDA Class 2 ·Orthopedic

MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·Dental

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

FDA 510(k)

FDA Class 2 ·Neurology

CARDITTE MICROTEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALADDIN HW3.0

FDA 510(k)

FDA Class 2 ·Ophthalmic

COSMED K5 Wearable Metabolic Technology

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kerasave

FDA 510(k)

FDA Class 2 ·Ophthalmic