AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cary

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NORDICBRAINEX SOFTWARE, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

nordicMEDiVA

FDA 510(k)

FDA Class 2 ·Radiology

ODI-Tech

FDA 510(k)

FDA Class 2 ·Cardiovascular

nordicBrainEx

FDA 510(k)

FDA Class 2 ·Radiology

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE

FDA 510(k)

FDA Class 2 ·Dental

TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

FDA 510(k)

FDA Class 2 ·Immunology

AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140

FDA 510(k)

FDA Class 2 ·Dental

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rexious Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW

FDA 510(k)

FDA Class 2 ·Radiology