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

OVE 2026-06-15

NeckTune™ 3D SA Cervical Cage

Applicant Medyssey Co, Ltd.

K-Number K260036

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QIH 2026-06-15

WatchMate Software

Applicant Anumana, Inc.

K-Number K260300

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KPR 2026-06-15

DRE Duo

Applicant Jpi Healthcare Co, Ltd.

K-Number K260482

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PGX 2026-06-15

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit

Applicant Diasorin Molecular, LLC

K-Number K260333

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QIH 2026-06-15

MediAI-OA

Applicant Crescom Co., Ltd.

K-Number K253172

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MQE 2026-06-15

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K-Number K253121

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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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