Eko Murmur Analysis Software (EMAS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITALCONNECT PLATFORM BY VITAL CONNECT INC.

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOLOR CARE TECHNOLOGIES CORPORATION OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CANDELA GENTLEMAX FAMILY OF LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CORE 500 Digital Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ethylene Oxide Sterilization Supplier Change for MPO Hips

FDA 510(k)

FDA Class 2 ·Orthopedic

KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTENDER SERIES II BAROSTAT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMEGA HA COATED TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ExactVu High Resolution Micro-Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Freezpoint

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KM-5 METAL BACKED ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CYGNUS-C Standalone ACIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

PATELLOFEMORAL JOINT PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry