Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PICO SMOKERLYZER, MODEL EC-50

FDA 510(k)

FDA Class 2 ·Anesthesiology

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

Wearable breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DISPOS. I/A & IRRIGATION HANDPIECES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MARQUETTE 1200 DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF MLT R694 RUBY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BAWMED RESCUE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Habib EUS RFA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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