HERA I10 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HS40 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS

FDA 510(k)

FDA Class 2 ·General Hospital

BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

ANTHRACIS REAL-TIME PCR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Variola virus Real-Time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

FDA 510(k)

FDA Class 2 ·Cardiovascular

BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200

FDA 510(k)

FDA Class 2 ·Cardiovascular

GXR-Series Diagnostic X-Ray System

FDA 510(k)

FDA Class 2 ·Radiology

Traus SSG10 Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

ORTIV (ORTIV-BL, ORTIV-WH)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

J2A SLA Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Endo Keeper

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EDEN ControlCath

FDA 510(k)

FDA Class 2 ·Anesthesiology

URIS Smart Path Implant System & Prosthetic

FDA 510(k)

FDA Class 2 ·Dental

EDEN Peek Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)

FDA 510(k)

FDA Class 2 ·Physical Medicine