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

EBG 2024-11-26

Digital Temp

Applicant Sprintray, Inc.

K-Number K242559

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MEH 2024-11-25

World Liner

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K243162

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NGX 2024-11-25

EMS Sculpt Machine

Applicant Shandong Huamei Technology Co., Ltd.

K-Number K232982

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GXY 2024-11-25

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)

Applicant Eemagine Medical Imaging Solutions GmbH

K-Number K240575

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ITI 2024-11-25

Electric Wheelchair (KR8803)

Applicant Zhejiang Kairui Medical Device Co., Ltd.

K-Number K241588

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PQA 2024-11-25

Aptima BV Assay; Aptima CV/TV Assay

Applicant Hologic, Inc.

K-Number K243345

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FRC 2024-11-25

3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

Applicant 3M Company

K-Number K242538

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QDQ 2024-11-25

Transpara (2.1.0)

Applicant Screenpoint Medical B.V.

K-Number K241831

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BZH 2024-11-25

Aluna 2

Applicant Knox Medical Diagnostics

K-Number K232588

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NHA 2024-11-25

Customized Abutment

Applicant Arum Dentistry Co., Ltd.

K-Number K242245

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DZE 2024-11-25

MIS LYNX Conical Connection Implant System

Applicant Dentsply Sirona, Inc.

K-Number K241692

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PHX 2024-11-25

JARVIS Glenoid Reverse Shoulder Prosthesis

Applicant FH Industrie

K-Number K242253

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