OPUS 20, MODEL 1ST

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InMode System with the Morpheus8 (Fractora) Applicators

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

H-FLOW VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Anesthesiology

Columbus Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

SafePort(TM) Manifold (or Stopcock)

FDA 510(k)

FDA Class 2 ·General Hospital

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

DSI Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

EmoLED (v. 2-USA)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL

FDA 510(k)

FDA Class 2 ·Radiology

PIEZOSURGERY 3; OSSTEM PIEZO

FDA 510(k)

FDA Class 2 ·Dental

BriefCase

FDA 510(k)

FDA Class 2 ·Radiology

SMR Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

TSP Crosser Transseptal Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Legend X Desktop System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·Dental

PULMOTRACK 2020 SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PIEZOSURGERY

FDA 510(k)

FDA Class 2 ·Dental