COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIMERTEST LATEX

FDA 510(k)

FDA Class 2 ·Hematology

UFI GEL HARD

FDA 510(k)

FDA Class 2 ·Dental

ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

FDA 510(k)

FDA Class 2 ·General Hospital

DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC

FDA 510(k)

FDA Class 2 ·Dental

EUROPA™ Navigated Instruments

FDA 510(k)

FDA Class 2 ·Neurology

DiLumen Endolumenal Interventional Scissors (DiLumen Is)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOMMANDER PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

DiLumen Endolumenal Interventional Platform

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ellusa Bipolar Wands

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Coconu Water Based Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SOLITAIRE-C CERVICAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMPUS(TM) CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OARtrac System

FDA 510(k)

FDA Class 2 ·Radiology

EffortMed Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

AIRO Suction Unit (AIRO-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUMESH DEPLOYMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery