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

FRO 2023-01-17

Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)

Applicant Winner Medical Co., Ltd.

K-Number K221754

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IPF 2023-01-17

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

Applicant Hilltek, LLC

K-Number K213655

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IYE 2023-01-17

Halcyon, Ethos Radiotherapy System

Applicant Varian Medical Systems, Inc.

K-Number K222941

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OAS 2023-01-17

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Applicant Cefla S.C.

K-Number K223794

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EHD 2023-01-17

Portable X-ray System

Applicant Iray Technology Taicang , Ltd.

K-Number K223010

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GEI 2023-01-17

Plasma IQ

Applicant Neauvia North America, Inc.

K-Number K223222

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MOS 2023-01-13

Contour Knee

Applicant Quality Electrodynamics, LLC

K-Number K223429

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FRO 2023-01-13

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing

Applicant Winner Medical Co., Ltd.

K-Number K221755

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GXP 2023-01-13

MONTAGE Settable, Resorbable Bone Putty

Applicant Orthocon, Inc.

K-Number K221933

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QRK 2023-01-13

Medipoint Blood Lancets

Applicant Medipoint Holdings, LLC

K-Number K223480

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HGX 2023-01-13

Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

Applicant Zhejiang Carebao Co., Ltd.

K-Number K222782

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CDZ 2023-01-13

Access Testosterone

Applicant Beckman Coulter, Inc.

K-Number K223405

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