IMMUNOCYT

FDA 510(k)

FDA Class 2 ·Hematology

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

FDA classification

FDA Class 2 ·System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Easi-Vue® embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Easi-Vue embolic microspheres System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

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

VIMPLANT

FDA 510(k)

FDA Class 2 ·Radiology

ACCUREX

FDA 510(k)

FDA Class 2 ·Radiology

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

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

DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

FDA 510(k)

FDA Class 2 ·Anesthesiology

HAMILTON-T1

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTILATOR #1

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEWPORT E500 WAVE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology