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

MAI 2025-02-05

GRYPHON X Anchor; HEALIX TRANSTEND Anchor

Applicant Depuy Mitek

K-Number K243790

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QIH 2025-02-05

BoneMetrics (US)

Applicant Gleamer Sas

K-Number K241593

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IPF 2025-02-05

TrainFES Advance

Applicant Trainfes

K-Number K241488

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DXN 2025-02-05

Accurate Mini Non-invasive blood pressure monitor (AMB-001)

Applicant Accurate Meditech, Inc.

K-Number K242352

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GEI 2025-02-05

CROMA Electrosurgical Generator (PRD-EMR-050)

Applicant Creo Medical, Ltd.

K-Number K242983

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FMF 2025-02-05

GraftGun Universal Graft Delivery System (GDS)

Applicant SurGenTec, LLC

K-Number K243580

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HAW 2025-02-05

Navient Image Guide Navigation System (955-NC-NC), Cranial

Applicant Claronav

K-Number K241327

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HWC 2025-02-05

Caliber Intramedullary Fixation System

Applicant Nvision Biomedical Technologies

K-Number K242896

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OLP 2025-02-05

LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

Applicant Shenzhen Eyco Technology Co., Ltd.

K-Number K243555

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BTA 2025-02-04

Geon (S2) Nasal Aspirator

Applicant Geon Corporation

K-Number K243138

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LPL 2025-02-04

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

Applicant Largan Medical Co., Ltd.

K-Number K242916

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GEI 2025-02-04

Venclose digiRF Generator (VCRFG1)

Applicant Venclose, Inc.

K-Number K250068

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