Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 2026-01-15

Electric Wheelchair (DH01168)

Applicant Foshan Dahao Medical Technology Co., Ltd.

K-Number K251458

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PHX 2026-01-15

N22 EZ Glenosphere

Applicant Shoulder Innovations, Inc.

K-Number K252516

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QEZ 2026-01-15

Aventus Thrombectomy System

Applicant Inquis Medical

K-Number K253925

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OUO 2026-01-15

BIOGRAPH One

Applicant Siemens Healthineers AG

K-Number K253023

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IYE 2026-01-15

EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)

Applicant Elekta Solutions AB

K-Number K252188

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HRS 2026-01-15

TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)

Applicant TriMed, Inc.

K-Number K254002

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MYN 2026-01-15

Diagnocat

Applicant DGNCT, LLC

K-Number K252934

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BZD 2026-01-15

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

Applicant Sleepnet Corporation

K-Number K251847

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LZO 2026-01-15

Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Applicant Maxx Orthopedics, Inc.

K-Number K253171

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GEI 2026-01-15

Ignite RF System

Applicant InMode , Ltd.

K-Number K251254

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PSZ 2026-01-15

Nano-Check Influenza A+B Test

Applicant Nano-Ditech Corporation

K-Number K252283

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PGM 2026-01-15

SDS Growing Rod

Applicant BAAT Medical Products B.V.

K-Number K251961

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