Vial2Bag Advanced® 13mm Admixture Device

FDA 510(k)

FDA Class 2 ·General Hospital

X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

FDA 510(k)

FDA Class 2 ·Hematology

Bonus Therapeutics Mixing and Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

INMODE WMBODY DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EpiFinder

FDA 510(k)

FDA Class 2 ·General Hospital

CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

OSSIOfiber® Staple

FDA 510(k)

FDA Class 2 ·Orthopedic

NIR BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LABORPRO SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

3DI

FDA 510(k)

FDA Class 2 ·Radiology

CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

FDA 510(k)

FDA Class 2 ·Cardiovascular

CarboClear® Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UltraSight AI Guidance

FDA 510(k)

FDA Class 2 ·Radiology

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

HOLOSCOPE-i

FDA 510(k)

FDA Class 2 ·Radiology