Brainlab Elements Guide XT, Guide 3.0

FDA 510(k)

FDA Class 2 ·Neurology

SureTune4 Software

FDA 510(k)

FDA Class 2 ·Neurology

Bullsai Confirm

FDA 510(k)

FDA Class 2 ·Neurology

Brain Stimulation Programming Planning Software.

FDA classification

FDA Class 2 ·Brain Stimulation Programming Planning Software.

Q.C. TESTER

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·Hematology

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QFC UMBILICAL CLAMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

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

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DENSICOMP 250

FDA 510(k)

FDA Class 2 ·Radiology

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BCM 400CP

FDA 510(k)

FDA Class 2 ·Radiology

BCM-400C

FDA 510(k)

FDA Class 2 ·Radiology

ARC-600

FDA 510(k)

FDA Class 2 ·Radiology

BCM-ARC 105 X-RAY MOBILE UNIT

FDA 510(k)

FDA Class 2 ·Radiology