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

NUC 2021-11-18

Water-soluble Personal Lubricant

Applicant Foshan Pingchuang Medical Technology Co., Ltd.

K-Number K212104

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FYC 2021-11-17

Protect X Level 3 Isolation Gown

Applicant Azac Group

K-Number K211538

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MMK 2021-11-17

Promisemed Sharps container

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K211890

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PHX 2021-11-17

Arthrex Modular Glenoid System-Titanium Glenosphere

Applicant Arthrex, Inc.

K-Number K212415

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LNH 2021-11-17

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Applicant Hyperfine, Inc.

K-Number K212456

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QDQ 2021-11-17

Lunit INSIGHT MMG

Applicant Lunit, Inc.

K-Number K211678

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FXX 2021-11-17

Disposable Surgical Mask

Applicant Suzhou Letian Protective Products Co., Ltd.

K-Number K210042

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KNT 2021-11-17

Qora Stool Management Kit

Applicant Cm Technologies, Inc.

K-Number K212444

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EIH 2021-11-17

BruxZir Esthetic

Applicant Prismatik Dentalcraft, Inc.

K-Number K213425

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OWB 2021-11-17

Soteria.AI

Applicant Omega Medical Imaging, LLC

K-Number K212336

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PIF 2021-11-16

Enteral Feeding Set

Applicant Kb Medical (Group), Inc.

K-Number K210854

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HWC 2021-11-16

Sterile PHALINX Hammertoe System

Applicant Wrightmedicaltechnologyinc

K-Number K212996

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