R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123

FDA 510(k)

FDA Class 2 ·General Hospital

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape

FDA 510(k)

FDA Class 2 ·General Hospital

MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)

FDA 510(k)

FDA Class 2 ·Neurology

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT

FDA 510(k)

FDA Class 2 ·General Hospital

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED LINER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST