RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Cocoon Convective Warming System, Model CWS7000

Care Essentials Pty, Ltd.

Wrist Blood Pressure Monitor

Zhuhai Yueja Medical Device Technology Co., Ltd.

Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (

Stryker Sustainability Solutions

Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs

Shandong Blue Sail Health Technology Co., Ltd.

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

VivaQuant, Inc.

Sterilization Pouches and Reels

Shanghai Jianzhong Medical Packaging Co., Ltd.

Stingray LP Catheter

Boston Scientific

MyPAO Guides

Medacta International S.A.

Electrical Scooter, WT-T4SU

W'U'S Tech Co., Ltd.

Oxygen Concentrator, Model JAY-5AW

Longfian Scitech Co., Ltd.

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)

Guangdong Golden Leaves Technology Development Co., Ltd.

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Co

Dentsply Sirona, Inc.

IMRIS iMRI 3T V

Deerfield Imaging, Inc.

ExcelsiusFlex™

Globus Medical, Inc.

BodySculp

Rohrer Aesthetics, LLC

Personalized Therapy Comfort Settings (PTCS)

Resmed Corp

TRUDERMAL Pro (ZLD-390)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

MTM301 Blood Glucose and Ketone Monitoring System

Apex BioTechnology Corp.

myAir

Resmed Corp

Gastric Alimetry

Alimetry , Ltd.

Teal Wand

Teal Health, Inc.

Gemini 2 810+980 Soft Tissue Laser

Azena Medical, LLC

Catapult Guide Sheath

Contract Medical International, GmbH

Play and Joy Water-Based Lubricant

Innovemed Bio-Tech Co., Ltd.

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Genesee Biomedical, Inc.

LOQTEQ® VA Elbow Plates 2.7/3.5 System

Aap Implantate AG

Stealth AXiS™ ENT clinical application

Medtronic Navigation, Inc.

Refobacin Bone Cement R (110034355)

Biomet France

Freedom® Total Knee System – Titanium Tibial Base Plate

Maxx Orthopedics, Inc.

Dura-Crown

Hangzhou SHINING3D Dental Technology Co., Ltd.

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