Oximeter, Wellness

FDA classification

FDA Class 2 ·Oximeter, Wellness

MOTO PFJ System

FDA 510(k)

FDA Class 2 ·Orthopedic

Entuit PEG, Entuit PEGJ

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Entuit PEG, Entuit PEGJ

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TANDEMHEART FEMORAL VENOUS CANNULA SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitalDetect

FDA 510(k)

FDA Class 2 ·General Hospital

MOTOTM Partial Knee & MOTO PFJ Systems Extension

FDA 510(k)

FDA Class 2 ·Orthopedic

BNOS MICRO VENT, MODEL AC AND MODEL AO

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pump In Style Advanced, Advanced Personal Double Breastpump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOL-GUARD Safety Pull Button Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alivio Ventricular Catheter and Flusher System (Alivio System)

FDA 510(k)

FDA Class 2 ·Neurology

TUTOPATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pump In Style

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Iontophoresis Electrodes

FDA 510(k)

FDA Class 2 ·Physical Medicine

MINIPHYSIONIZER 2.0 AND ELECTRODES

FDA 510(k)

FDA Class 2 ·Physical Medicine