Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON PLEX Respiratory Flex Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

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

QiF Blood and Fluid Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

QiF Blood and Fluid Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

QiF Blood and Fluid Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

QiF Blood and Fluid Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES

FDA 510(k)

FDA Class 2 ·Cardiovascular

DESCENDING ARCH CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015

FDA 510(k)

FDA Class 2 ·Cardiovascular

RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

External Counterpulsation System, Soulaire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LeadCare Plus Blood Lead Testing System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LEADCARE BLOOD LEAD TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology