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

ITI 2026-06-15

Electric Wheelchair (S500-6)

Applicant Zhongshan Sulenz Intelligent Technology Co., Ltd.

K-Number K260335

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OLR 2026-06-15

Curajel™ Oral Gel

Applicant USpharma, Ltd.

K-Number K260126

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QIH 2026-06-15

LungMaps

Applicant Siemens Healthineers AG

K-Number K253690

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QDQ 2026-06-15

Saige-Dx

Applicant DeepHealth, Inc.

K-Number K253825

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PML 2026-06-15

Dynamo™ Spinal Cement; Salvo® Spine System

Applicant Spine Wave, Inc.

K-Number K260286

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MAX 2026-06-15

Fule Interbody Fusion Cage System

Applicant Beijing Fule Science & Technology Development Co., Ltd.

K-Number K253151

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N/A 2026-06-15

VERAFEYE Imaging and Guidance System (VF-VIS-002)

Applicant Luma Vision Limited

K-Number K260885

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LXB 2026-06-15

Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

Applicant Zdeer Technology (Henan) Co., Ltd.

K-Number K260452

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GWQ 2026-06-13

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

Applicant Neuroelectrics Barcelona S.L.U.

K-Number K261604

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MWI 2026-06-12

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

Applicant Midmark Corporation

K-Number K253196

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IYE 2026-06-12

ThinkQA 3

Applicant Dosisoft SA

K-Number K252937

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PHX 2026-06-12

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

Applicant Stryker Corporation (Tornier, Inc.)

K-Number K260102

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