ORION

FDA 510(k)

FDA Class 2 ·Ophthalmic

DEKA SYNCHRO FT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

NuEra Tight RF Model OptiStream

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HS AMICA DEVICES FAMILY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lp(a) Ultra

FDA 510(k)

FDA Class 2 ·Immunology

YOULASER CO2 LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOGRAPH DC

FDA 510(k)

FDA Class 2 ·Dental

LITHO DK30

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

(QUANTA SYSTEM) SURGICAL LASER FIBERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

G-scan Brio

FDA 510(k)

FDA Class 2 ·Radiology

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

FDA 510(k)

FDA Class 2 ·Anesthesiology

STA COMPACT MAX

FDA 510(k)

FDA Class 2 ·Hematology

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

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