510(k) Device Clearances

SelectSite C304 Deflectable Catheter System, C315 Delivery System

Medtronic

Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

Tornier, Inc.

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with

Better Care Plastic Technology Co., Ltd.

Ponto 5 SuperPower

Oticon Medical AB

InSee

Tidal Medical Technologies, LLC

LevaLap Laparoscopic Access Device

Core Access Surgical Technologies, Inc.

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

Amptron Medical, Inc.

EVOS Wrist Spanning Plate

Smith & Nephew, Inc.

Uresta®

Resilia, Inc.

Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Rep

Conformis, Inc.

RODEO Telescopic Nail

Orthofix Srl

ALPHALOK Plating System

Vilex, LLC

NextAR Hip Platform

Medacta International S.A.

Pre-Sure

Lazarus 3D

Resitu Slider 09 (RESL09)

Resitu Medical AB

NEUROMARK System (NMK00301)

Neurent Medical , Ltd.

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (

Alcon Laboratories, Inc.

BTI Interna Dental Implant System UnicCa - Prosthetic Components

B.T.I. Biotechnology Institute, Sl.

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

Smwmed, Inc.

ClearCheck (RADCC V2.7)

Radformation, Inc.

Qora Stool Management Kit

Cm Technologies, Inc.

GR Resin System MSI

Pro3Dure Medical

Excipio SV Aspiration Catheter and Tubing

Contego Medical, Inc.

Spine Navigation System

Medivis, Inc.

3DOSE 1ml Syringe

Bimed Teknik Aletler Sanayi & Ticaret A.S.

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)

Hunan Haipuming Technology Co., Ltd.

Vydence Zye and Vydence One

Vydence Medical Industria E Comercio Ltda

els unibond

Saremco Dental AG

Encora X1

Encora, Inc.

Mpact 3D Metal Augments II

Medacta International S.A.