BioFlo Midline Catheter

FDA 510(k)

FDA Class 2 ·General Hospital

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

FDA 510(k)

FDA Class 2 ·Dental

PIEZON 250

FDA 510(k)

FDA Class 2 ·Dental

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXPEDIUM SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GSP NEONATAL THYROXINE (T4)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLEXIVA TRACTIP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DENVER PERITONEO-VENOUS SHUNT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PULPDENT MICROFILLED ANTERIOR COMPOSITE

FDA 510(k)

FDA Class 2 ·Dental

ECTRA LIGAMENT RELEASE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MITEK GII ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

SCD(R) CONTROLLER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Inspan ScrewLES Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIOMED 15, 30, 60 SURGICAL DIODE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OPUS RUBELLA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Overjet Image Enhancement Assist

FDA 510(k)

FDA Class 2 ·Radiology