GLUCOFILM TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AETMED IMAGE PROCESSING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH

FDA 510(k)

FDA Class 2 ·Neurology

AMK LANDMARK REVISION KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPREHENSIVE CONVERTIBLE GLENOID

FDA 510(k)

FDA Class 2 ·Orthopedic

RXPEAKFLOW

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY

FDA 510(k)

FDA Class 2 ·Orthopedic

ISE INDIRECT NA, K, C1 FOR GEN 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Renal Access Cobra Catheter, Kumpe Access Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRECISET TDM I AND PRECISET TDM II CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIVONA TRACHEOSTOMA VALVE II

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARTHROTEK MENISCAL HYBRID DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZIMMER M/L TAPER HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

POROUS APF/MODULAR FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular