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

Over-The-Counter Covid-19 Antigen Test

FDA classification

FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification

FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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

RSCRIBE ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

HL168F

FDA 510(k)

FDA Class 2 ·Cardiovascular

HydroPearl Microspheres, HydroPearl Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular