MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

FDA 510(k)

FDA Class 2 ·Orthopedic

MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)

FDA 510(k)

FDA Class 2 ·Orthopedic

MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Midline Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

MySpine Unilateral Guides

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

Pedicle Screw Placement Guide

FDA classification

FDA Class 2 ·Pedicle Screw Placement Guide

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

FDA 510(k)

FDA Class 2 ·Hematology

PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD

FDA 510(k)

FDA Class 2 ·Radiology

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.

FDA 510(k)

FDA Class 2 ·Ophthalmic

KERR PORCELITE

FDA 510(k)

FDA Class 2 ·Dental

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

SQA

FDA 510(k)

FDA Class 2 ·Hematology

INSTRUMENTARIUM ULF MR IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

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

PATIENT VALVE WITH AIR ENTRAINMENT

FDA 510(k)

FDA Class 2 ·Anesthesiology