Mi-CHORD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Artificial Chordae Tendineae Surgical Replacement System

FDA classification

FDA Class 2 ·Artificial Chordae Tendineae Surgical Replacement System

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BSK-1033 TELEMETRY MONITORING CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easi-Vue® embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easi-Vue embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

FMT Disposable and Autoclavable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

AAIO-7, AAIO WIRLESS

FDA 510(k)

FDA Class 2 ·Ophthalmic

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

FDA 510(k)

FDA Class 2 ·Radiology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Nucleoss Tpure Implant System

FDA 510(k)

FDA Class 2 ·Dental

MSFX Mikron Cervical Anterior Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Parky App

FDA 510(k)

FDA Class 2 ·Neurology

Altera gas Sampling Lines

FDA 510(k)

FDA Class 2 ·Anesthesiology