NuEra Tight, NuEra Tight EMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMR Finned Short Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

DEKA LILY

FDA 510(k)

FDA Class 2 ·Physical Medicine

Discovery Pico Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PureFlex Arterial Cannulae

FDA 510(k)

FDA Class 2 ·Cardiovascular

TrueLok Evo

FDA 510(k)

FDA Class 2 ·Orthopedic

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES

FDA 510(k)

FDA Class 2 ·General Hospital

TRAP EASY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MT-Bone

FDA 510(k)

FDA Class 2 ·Dental

TrueLok Elevate

FDA 510(k)

FDA Class 2 ·Orthopedic

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,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

FDA 510(k)

FDA Class 2 ·Cardiovascular

Deka Bluebeam

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

FDA 510(k)

FDA Class 2 ·Cardiovascular

Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

LIAC HWL

FDA 510(k)

FDA Class 2 ·Radiology

LIASYS 450

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Prettau, ICE, Z-White zirconia blanks

FDA 510(k)

FDA Class 2 ·Dental

THD N-ANO ANOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

G3 40 Radiopaque Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Pantheon Proximal Femur Reconstruction (PFR) System

FDA 510(k)

FDA Class 2 ·Orthopedic