ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOFLIP CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

XVI R4.5

FDA 510(k)

FDA Class 2 ·Radiology

AcuPulse CO2 Laser System, Delivery Devices and Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

xvision Spine System

FDA 510(k)

FDA Class 2 ·Neurology

HABIB HEXABLATE 10

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGERY AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Radiology

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER

FDA 510(k)

FDA Class 2 ·Hematology

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

VPAP TX

FDA 510(k)

FDA Class 2 ·Anesthesiology

RITRACT SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

Hyper GP (tisilfocon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V

FDA 510(k)

FDA Class 2 ·General Hospital

BrainsWay Deep TMS System

FDA 510(k)

FDA Class 2 ·Neurology

WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS

FDA 510(k)

FDA Class 2 ·Radiology

PROBEAT-CR

FDA 510(k)

FDA Class 2 ·Radiology

Brainsway Deep TMS System

FDA 510(k)

FDA Class 2 ·Neurology