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

GAM 2024-10-11

Monotime and Optime R

Applicant Peters Surgical

K-Number K233265

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ODC 2024-10-11

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

Applicant STERIS Corporation

K-Number K242742

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LPH 2024-10-11

Legend® Acetabular Shell

Applicant Ortho Development Corp.

K-Number K242833

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MUH 2024-10-11

X Sensor (Model: IOS-A15IF, HDI-15DGF)

Applicant Qpix Solutions, Inc.

K-Number K242778

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DZE 2024-10-11

JDZygoma dental implants

Applicant Jdentalcare Srl

K-Number K240143

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OBO 2024-10-11

SPECTRALIS with Flex Module

Applicant Heidelberg Engineering GmbH

K-Number K241163

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LLZ 2024-10-11

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K241569

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PNN 2024-10-11

Progressive Orthodontics App

Applicant Progressive Aligners, Inc.

K-Number K241153

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DQK 2024-10-11

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)

Applicant Centerline Biomedical, Inc.

K-Number K242133

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LGD 2024-10-11

Access Toxo IgM II

Applicant Beckman Coulter, Inc.

K-Number K242095

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INI 2024-10-11

Mobility Scooter (N3473)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K242387

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OHS 2024-10-11

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

Applicant Dongguan Boyuan Intelligent Technology Co.,Ltd

K-Number K241857

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