Zenition 90

FDA 510(k)

FDA Class 2 ·Radiology

dS FootAnkle Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

dS Knee Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

XPERGUIDE

FDA 510(k)

FDA Class 2 ·Radiology

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

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 on the High Pure System

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602

Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

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 V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM

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

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

FDA 510(k)

FDA Class 2 ·Radiology

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