SMR Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

WINSIX Implant System

FDA 510(k)

FDA Class 2 ·Dental

KITE Distal Fibula Kit

FDA 510(k)

FDA Class 2 ·Orthopedic

MrOpen

FDA 510(k)

FDA Class 2 ·Radiology

Lexa MINI (RIS-303, RIS-305)

FDA 510(k)

FDA Class 2 ·General Hospital

RAPIDO HOLLOW-FIBRE DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GPC Intraheal Intramedullary Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

ECG HOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

PodSKAN HF Diagnostic X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

MP-1 MICROPERIMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

CRP DIAGNOSTIC ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

INVIGRA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Frontier X Plus

FDA 510(k)

FDA Class 2 ·Cardiovascular

Discovery Pico, Discovery Pico Plus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Scrambler Therapy MC-5 A Device

FDA 510(k)

FDA Class 2 ·Neurology

Torc Body

FDA 510(k)

FDA Class 2 ·Physical Medicine

Pentaflush

FDA 510(k)

FDA Class 2 ·General Hospital

FIAB SPA, MODELS F7244, F7233, F7234, F7277

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery