MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001

FDA 510(k)

FDA Class 2 ·Radiology

Anti-Jcv Antibody Detection Assay

FDA classification

FDA Class 2 ·Anti-Jcv Antibody Detection Assay

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

FDA classification

FDA Class 2 ·Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Syringe, Balloon Inflation

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

FDA classification

FDA Class 2 ·Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit

Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTELLIBRIDGE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORDIS 13F CATHETER SHEATH INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUTE CARDIAC CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular