IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT

FDA 510(k)

FDA Class 2 ·Microbiology

Vision Monitor - MonpackONE

FDA 510(k)

FDA Class 2 ·Neurology

EOlife®

FDA 510(k)

FDA Class 2 ·Anesthesiology

MammoScreen BD

FDA 510(k)

FDA Class 2 ·Radiology

Novae® Dual Mobility System, Hype® Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

SYMMETRIC TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GUS TRAC C-303

FDA 510(k)

FDA Class 2 ·Physical Medicine

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BI-MENTUM dual mobility system

FDA 510(k)

FDA Class 2 ·Orthopedic

TBS iNsight

FDA 510(k)

FDA Class 2 ·Radiology

IP-SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nutricair Enteral Syringe with ENFit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AKUPORT M-2

FDA 510(k)

FDA Class 2 ·Neurology

SYMMETRIC TOTAL KNEE AGUMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MammoScreen® (3)

FDA 510(k)

FDA Class 2 ·Radiology

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

FDA 510(k)

FDA Class 2 ·Cardiovascular

MammoScreen® (4)

FDA 510(k)

FDA Class 2 ·Radiology

KeriFlex® MCP and PIP Finger Joint Prostheses

FDA 510(k)

FDA Class 2 ·Orthopedic