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

FXX 2025-09-17

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)

Applicant Vitacore Industries, Inc.

K-Number K251902

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LYC 2025-09-17

FG Bone Graft M

Applicant Full Golden Biotech Co., Ltd.

K-Number K244006

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LPL 2025-09-17

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

Applicant Pegavision Corporation

K-Number K251095

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IRP 2025-09-17

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

Applicant Shenzhen Yicai Health Technology Co., Ltd.

K-Number K251623

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LNH 2025-09-17

ECHELON Synergy

Applicant Fujifilm Corporation

K-Number K251386

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EBI 2025-09-17

DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

Applicant Kamemizu Chemical Industry Co., Ltd.

K-Number K252035

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QWL 2025-09-17

Ruthless Spine RJB

Applicant Ruthless, LLC Dba Ruthless Spine

K-Number K252615

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MSS 2025-09-16

ACCUJECT Injector Set 2.1-1P (LP604590)

Applicant Medicel AG

K-Number K252540

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LHI 2025-09-16

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

Applicant Microtek Medical, LLC

K-Number K251676

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NHA 2025-09-16

SFIT Abutment

Applicant Cowellmedi Co., Ltd.

K-Number K242287

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JAA 2025-09-16

Insight Enhanced DRF (EN-1002-01)

Applicant Imaging Engineering, LLC

K-Number K251650

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OHT 2025-09-15

IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)

Applicant Miley Technology (Hebei) Co., Ltd.

K-Number K251914

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