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

FDA 510(k)

FDA Class 2 ·Hematology

Jac-Cell Medic testers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PULSE-AID DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intraocular Pressure Tonometer EASYTON

FDA 510(k)

FDA Class 2 ·Ophthalmic

INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

J2A Dental Implant System, J2C Dental Implant System

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

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

oCare Wrist Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

RSI FEMORAL GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT

FDA 510(k)

FDA Class 2 ·General Hospital

AMICAS VISION SERIES PACS, MODEL 4.3

FDA 510(k)

FDA Class 2 ·Radiology

AMICAS PACS, VERSION 6.0

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

DENSICOMP 250

FDA 510(k)

FDA Class 2 ·Radiology

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

BCM 400CP

FDA 510(k)

FDA Class 2 ·Radiology