EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOCAP CMX-104 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DELFIA HTSH ULTRA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Planmeca Romexis

FDA 510(k)

FDA Class 2 ·Radiology

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DePuy Reclaim Monobloc Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPNOMAC ULTIMA ANESTHESIA MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Planmed Verity

FDA 510(k)

FDA Class 2 ·Radiology

Toricolors (hioxifilcon D) Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPUS AFP - ALPHA-FETOPROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLOBAL UNITE Platform Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic