FTA-ABS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O

FDA 510(k)

FDA Class 2 ·Radiology

Bilicocoon™ Phototherapy System

FDA 510(k)

FDA Class 2 ·General Hospital

FTA-ABS BIOPAK

FDA 510(k)

FDA Class 2 ·Microbiology

FTA-ABS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

LAB-TEK FTA-ABS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

POLYCHACO FIA-ABS TEST FOR SYPHILIS

FDA 510(k)

FDA Class 2 ·Microbiology

Digiscan FDX

FDA 510(k)

FDA Class 2 ·Radiology

Cardiovascular Angiography System

FDA 510(k)

FDA Class 2 ·Radiology

DigiX FDX

FDA 510(k)

FDA Class 2 ·Radiology

Wireless/Wired X-Ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

JUVORA DENTQAL DISC

FDA 510(k)

FDA Class 2 ·Dental

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

FDA 510(k)

FDA Class 2 ·Dental

JUVORA Dental Disc, Ceramill PEEK by JUVORA

FDA 510(k)

FDA Class 2 ·Dental

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

BT-1000

FDA 510(k)

FDA Class 2 ·Neurology

Hi bebe super (Models BT-150S and BT-150L)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Infant Phototherapy Equipment

FDA 510(k)

FDA Class 2 ·General Hospital

Hi bebe plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery