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

MAX 2022-07-27

Pegasus-X Expandable PLIF System

Applicant GS Medical Co., Ltd.

K-Number K221687

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ETD 2022-07-27

Hummingbird Tympanostomy Tube System

Applicant Preceptis Medical, Inc.

K-Number K221254

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OLO 2022-07-27

Real Intelligence Cori

Applicant Blue Belt Technologies, Inc.

K-Number K220958

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FXX 2022-07-27

AOK 95A Medical Mask (20200049)

Applicant Aok Tooling Limited

K-Number K220876

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OHS 2022-07-27

reVive Light Therapy LED Cleansing System

Applicant Led Technologies, Inc.

K-Number K221430

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LZA 2022-07-27

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Shandong Maida Medical Technology Co., Ltd.

K-Number K221271

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DQK 2022-07-27

DeepRhythmAI

Applicant Medicalgorithmics S.A.

K-Number K210822

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PFO 2022-07-27

Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

Applicant Cochlear Americas

K-Number K220922

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OUR 2022-07-27

TransLoc 3D

Applicant Foundation Fusion Solutions, LLC (Dba Cornerloc)

K-Number K211496

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GEX 2022-07-27

Dornier Thulio

Applicant Dornier Medtech America, Inc.

K-Number K213252

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DXX 2022-07-27

CorPath GRX System

Applicant Corindus, Inc.

K-Number K221464

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NXO 2022-07-26

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

Applicant DiaSorin, Inc.

K-Number K213858

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