MAMMOSITE MULTI LUMEN

FDA 510(k)

FDA Class 2 ·Radiology

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INVADER MTHFR 677

FDA 510(k)

FDA Class 2 ·Hematology

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

SINGLE ENERGY (SE) FEMUR EXAMS

FDA 510(k)

FDA Class 2 ·Radiology

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology

QDR-1000 AND WITH X-RAY BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

FDA 510(k)

FDA Class 2 ·Radiology

BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

BONE MINERAL DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

MyoSure MANUAL Tissue Removal Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Aptima SARS-CoV-2 Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Affirm Prone Biopsy System

FDA 510(k)

FDA Class 2 ·Radiology

MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

Genius AI Detection 2.0 with CC-MLO Correlation

FDA 510(k)

FDA Class 2 ·Radiology

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology