ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Adult Cannulae Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Pediatric Cannula and Introducers

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Insertion Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONALIS, MODEL 2000

FDA 510(k)

FDA Class 2 ·Radiology

EYETRACKER/IDEAS

FDA 510(k)

FDA Class 2 ·Neurology

6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II™ Insertable Cardiac Monitor (LNQ22)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Apex Tibial Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Apex Femoral Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0