ONQ RTS

FDA 510(k)

FDA Class 2 ·Radiology

Elvie Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

firefly T-2

FDA 510(k)

FDA Class 2 ·Physical Medicine

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO E.P.T. PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

FDA 510(k)

FDA Class 2 ·Orthopedic

Deltex Medical KDP72 Doppler Probe

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lustre PRO Light System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Neurosign V4 Intraoperative Nerve Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

EPT CERTAINTY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

DELTA T

FDA 510(k)

FDA Class 2 ·Anesthesiology

DECAPINOL ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

OCTEIA INTACT PTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TEMPUS PRO WITH ENHANCED FEATURES

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODY CLOCK STIMPLUS AND STIMPLUS PRO

FDA 510(k)

FDA Class 2 ·Neurology

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

FDA 510(k)

FDA Class 2 ·Radiology