ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRYPTIK2C-plate Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ROMEO 2 PAD POSTERIOR AXIAL DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET OL

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET LL

FDA 510(k)

FDA Class 2 ·Orthopedic

Perla Posterior Cervico-Thoracic Fixation system

FDA 510(k)

FDA Class 2 ·Orthopedic

Romeo posterior osteosynthesis system

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET PO

FDA 510(k)

FDA Class 2 ·Orthopedic

SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION

FDA 510(k)

FDA Class 2 ·Orthopedic

Juliet® Ti

FDA 510(k)

FDA Class 2 ·Orthopedic

JULIET® LL Lateral Lumbar Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navi-Star Diagnostic/Ablation Deflectable Tip Catheter

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

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 3 BONE CEMENT

DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.

FDA 510(k)

FDA Class 2 ·General Hospital

THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE

FDA 510(k)

FDA Class 2 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON