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

IRP 2025-09-18

Normatec Elite Hip

Applicant NormaTec Industries, LP

K-Number K251905

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HGX 2025-09-18

Magic InBra

Applicant Medela AG

K-Number K251377

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KRH 2025-09-17

Carpentier-Edwards Physio Annuloplasty Ring (4450)

Applicant Edwards Lifesciences, LLC

K-Number K251688

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MXD 2025-09-17

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

Applicant Abbott

K-Number K251221

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LRK 2025-09-17

Double Tube Herbst Appliance

Applicant The Tmj Clinic PC

K-Number K243752

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JOW 2025-09-17

PlasmaFlow X Compression Sleeve Device (XPF0001)

Applicant Manamed, LLC

K-Number K251446

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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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