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

DQK 2026-09-17

EnSite™ X EP System

Applicant Abbott Medical

K-Number K261729

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LZO 2026-09-17

M-Vizion Femoral Revision System Extension

Applicant Medacta International S.A.

K-Number K260173

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GZT 2026-09-17

Durashield Device Kit

Applicant SurGenTec, LLC

K-Number K252995

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GEI 2026-09-17

HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)

Applicant Ethicon Endo-Surgery, LLC

K-Number K254196

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MBH 2026-09-17

Unity Total Knee System, Unity Knee Cementless CR Femur

Applicant Corin, Ltd.

K-Number K261275

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MBI 2026-09-17

Integrity Retractable Implant Inserter (6000127)

Applicant Anika Therapeutics, Inc.

K-Number K261869

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PEM 2026-09-17

Hygienic Protective Bite Cover (2207-010-50)

Applicant Dürr Dental SE

K-Number K262073

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OLT 2026-09-16

Ceribell EEG Analysis Software

Applicant Ceribell, Inc.

K-Number K261712

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FDS 2026-09-16

Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

Applicant Ambu A/S

K-Number K261400

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ELW 2026-09-16

Dia-X Sil Light Body

Applicant DiaDent Group International

K-Number K254152

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OBR 2026-09-16

Mouth Guard

Applicant ChangSha ChuangDuoLe E-Commerce Co., Ltd.

K-Number K262559

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LNH 2026-09-16

APERTO Lucent MRI System

Applicant Fujifilm Corporation

K-Number K261283

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