VARIANT II TURBO Link HbA1c Program

FDA registration

Bio-Rad Laboratories, Inc.·1 product·🇺🇸 United States

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

NITREX™

FDA UDI

EV3, INC·00763000185343·GW N140801 NITREX V04

NITREX™

FDA UDI

Covidien LP·00821684058107·GW N140801 NITREX V03

NITREX

FDA UDI

Covidien LP·10821684009007·Guidewire

HOSMED

FDA registration

HOSMED INC.·3 products·🇺🇸 United States

Panther OIS

FDA registration

PROWESS, INC.·2 products·🇺🇸 United States

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin

Triton 2L Canister Insert Kit

FDA registration

R.H. CROSS ENTERPRISES, INC.·1 product·🇺🇸 United States

n/a

FDA UDI

Ortho Development Corporation·00822409067121·Stem Extension Trial Diameter 14x80mm

n/a

FDA UDI

Ortho Development Corporation·00822409070374·Snap-on Fem Augment Trial 8mm Distal Size 4

PUMA MODEL VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

INTRA-AORTIC BALLOON (IAB)

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Balloon, Intra-Aortic And Control

FDA classification

FDA Class 2 ·System, Balloon, Intra-Aortic And Control

Accelerator, Linear, Medical

FDA classification

FDA Class 2 ·Accelerator, Linear, Medical