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

OWQ 2022-05-25

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Applicant Innovative Health, LLC

K-Number K210655

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GEX 2022-05-25

InnoVoyce Laser Fiber

Applicant Innovoyce, LLC

K-Number K220793

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OLP 2022-05-25

Micro-current facial cold and hot service (model: TPML-100)

Applicant Li-Tek Electronics Technology C0., Ltd.

K-Number K213039

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DZE 2022-05-25

Paltop Conical Implant System

Applicant Paltop Advanced Dental Solutions, Ltd.

K-Number K220200

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QSR 2022-05-24

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

Applicant Medacta International S.A.

K-Number K220888

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FXX 2022-05-24

Disposable Face Mask

Applicant Jiujiang Taixin Technology Co., Ltd.

K-Number K220191

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LXC 2022-05-24

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K220952

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QSA 2022-05-24

Parsortix PC1 Device

Applicant Angle Europe , Ltd.

K-Number DEN200062

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LZO 2022-05-24

M-Vizion Monobloc

Applicant Medacta International S.A.

K-Number K212327

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LRO 2022-05-24

Medline General Surgery Tray

Applicant Medline Industries, Inc.

K-Number K213481

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LGZ 2022-05-24

S-Line

Applicant Barkey GmbH & Co. KG

K-Number K213191

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LPH 2022-05-24

BENCOX Mirabo Z Cup Cortinium

Applicant Corentec Co., Ltd.

K-Number K210614

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