OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275

FDA 510(k)

FDA Class 2 ·Neurology

THERATRON-PHOENIX

FDA 510(k)

FDA Class 2 ·Radiology

SPIVEY-ALLEN ORBITAL FLOOR IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

ACCUHEART ELECTRODE BELT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION

FDA 510(k)

FDA Class 2 ·Radiology

MED-RX ORAL/ENTERAL SYRINGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)

FDA 510(k)

FDA Class 2 ·Neurology

COX MALAR EMINENCE IMPLANTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SYNERMED DIRECT BILIRUBIN REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO-SEAL LUNG BIOPSY TRACT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MINISTRIP/ SERUM AND URINE COMBO HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

SONIX ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

SPY Elite Intraoperative Perfusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

THERATON 1000E

FDA 510(k)

FDA Class 2 ·Radiology

3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

EUNITY

FDA 510(k)

FDA Class 2 ·Radiology

DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)

FDA 510(k)

FDA Class 2 ·Radiology

Denti.AI Detect

FDA 510(k)

FDA Class 2 ·Radiology