GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra

FDA 510(k)

FDA Class 2 ·Radiology

VENTURI MiNO TG600/14

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cogent Hemodynamic Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Spirit Hair Removal laser Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

FDA 510(k)

FDA Class 2 ·Hematology

M500-100 SHARPS CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

GLYCOSYLATED HEMOGLOBIN KIT

FDA 510(k)

FDA Class 2 ·Hematology

FIBRI QUIK

FDA 510(k)

FDA Class 2 ·Hematology

DESERET HEPARIN COATED FLOW DIRECTED

FDA 510(k)

FDA Class 2 ·Cardiovascular

Home use hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

Micro Catheter and Guidewire System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

FDA 510(k)

FDA Class 2 ·Orthopedic

Atrial Fibrillation History Feature

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOL-X INTRODUCER, MODEL CF00200

FDA 510(k)

FDA Class 2 ·Cardiovascular

SnapShot Freeze 2

FDA 510(k)

FDA Class 2 ·Radiology

Arterys MICA

FDA 510(k)

FDA Class 2 ·Radiology

ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology