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

DXH 2021-06-30

KardiaMobile 6L

Applicant AliveCor, Inc.

K-Number K210753

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GCJ 2021-06-30

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0

Applicant Fujifilm Corporaton

K-Number K203717

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HRS 2021-06-29

Smith & Nephew Plates and Screws

Applicant Smith & Nephew, Inc.

K-Number K210837

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LNH 2021-06-29

STAGE

Applicant Spintech, Inc.

K-Number K210843

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PGY 2021-06-29

12MP Color Digital Mammography LCD Monitor CL-S1200

Applicant Jvckenwood Corporation

K-Number K203733

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FXX 2021-06-29

Nordiwell Surprotect Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K-Number K210445

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KNT 2021-06-29

Standard Bougie, 38 Fr.

Applicant Standard Bariatrics

K-Number K210437

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OAP 2021-06-29

Biophotas Celluma RESTORE

Applicant Biophotas, Inc.

K-Number K211038

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MUJ 2021-06-29

RayStation 10.1

Applicant RaySearch Laboratories AB (PUBL)

K-Number K210645

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OHS 2021-06-29

Synergy

Applicant Yrs Group, Inc.

K-Number K210954

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IYN 2021-06-29

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

Applicant Supersonic Imagine

K-Number K203645

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LZA 2021-06-28

White Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210775

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