510(k) Device Clearances

Ticare Dental Implant Systems

Mozograu S.A.

Urocross Expander System (UES-2018-C1)

Prodeon Medical, Inc.

Elite iQ PRO (M122K1)

Cynosure, LLC

Esophageal TTS Stent

Taewoong Medical

MAGiC Sweep™ EP Mapping Catheter

Stereotaxis, Inc.

Onflex™ Mesh

Davol Inc., Subsidiary of C. R. Bard, Inc.

Powder Free Nitrile Examination Glove

Daxwell, LLC

SkinSmart Antimicrobial HydroGel

Magic Science Supply, LLC

Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint

Medtronic, Inc.

BIOTEQ Drainage Catheter BT-PDS-series

Bioteque Corporation

Procedure mask/Surgical mask/Face mask

Winner Medical Co., Ltd.

Celerity Incubator

STERIS Corporation

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

Manual Wheelchair (7101L, 7102LHD)

Foshan Nanhai Hongchen Medical Equipment Co., Ltd.

OsteoCentric Spine MIS Pedicle Fastener System

OsteoCentric Technologies

CoolSculpting Elite System

Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Abla

ABBOTT MEDICAL

Any-Com Seal

Mediclus Co., Ltd.

ORi

Masimo Corporation

Powder Free Nitrile Examination Gloves (Blue)

Kgm Gloves Sdn. Bhd.

EEA Circular Stapler with Tri-Staple Technology

Covidien

Salvo® Robotic Navigation Instruments

Spine Wave, Inc.

CADDIE

Odin Medical Limited

Reusable Interface Cable 1.5 m (PRD-IFC-002)

Creo Medical, Ltd.

Rejoyn

Otsuka America Pharmaceutical, Inc.

Dolphin Blue Imaging

Patterson Dental Supply, Inc.

HyperVue™ Imaging System

Spectrawave, Inc.

ClaveQS™ Bag

Icu Medical, Inc.

Interwedge® Standalone Lateral

Foundation Surgical Group, Inc.

Cleerly LABS (v2.0)

Cleerly, Inc.