Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FLL 2019-10-15

Infared Thermometer

Applicant Shenzhen Calibeur Industries Co., Ltd.

K-Number K191251

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MAX 2019-10-15

DualX Lumbar Intervertebral Body Fusion Device

Applicant Amplify Surgical, Inc.

K-Number K192434

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FYA 2019-10-15

TotalShield II Surgical Helmet System

Applicant Zimmer Surgical, Inc.

K-Number K192194

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KCT 2019-10-15

Medtronic Transportation / Sterilization Cassettes

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K190840

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NFO 2019-10-15

NuFACE Mini Device

Applicant Carol Cole Company Dba Nuface

K-Number K191672

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OXC 2019-10-14

Echelon Endopath Staple Line Reinforcement

Applicant Ethicon Endo-Surgery, LLC

K-Number K190937

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NUH 2019-10-11

Electronic Pulse Stimulator

Applicant Shenzhen Leading Perfection Technology Co., Ltd.

K-Number K183674

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NUC 2019-10-11

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)

Applicant Trigg Laboratories, Inc. D/B/A Wet International

K-Number K191480

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BZD 2019-10-11

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K190713

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NGX 2019-10-11

NXPRO Neuromuscular Electrical Stimulation Device

Applicant Neux Technologies, Inc.

K-Number K191181

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EMA 2019-10-11

Nexus Universal Self-Cure

Applicant Kerr Corporation

K-Number K191548

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KNT 2019-10-11

McLean-Ring Enteral Feeding Tube Set

Applicant Cook Incorporated

K-Number K190084

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