VITAL CONNECT 4.1

FDA 510(k)

FDA Class 2 ·Radiology

LTF-Y0009; MAJ-YOO41; XOEV-3D1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

XPERT FLU/RSV XC ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

HUMAPEN LUXURA HD

FDA 510(k)

FDA Class 2 ·General Hospital

SURGICAL TISSUE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STRATUS CS D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

DADE THROMBIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

FDA 510(k)

FDA Class 2 ·Immunology

ICT

FDA 510(k)

FDA Class 2 ·Radiology

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION VISTA FLEX REAGENT CARTRIDGES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OsOpia Synthetic Bone Void Filler

FDA 510(k)

FDA Class 2 ·Dental

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC

FDA 510(k)

FDA Class 2 ·Radiology