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

FET 2025-02-07

Endoscopic Video Image Processor (RP-IPD-V1000F)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K243321

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GEX 2025-02-07

HELIOS 785 Pico (1754V2)

Applicant Laseroptek Co., Ltd.

K-Number K243780

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EIA 2025-02-07

BDC Dental Unit

Applicant Bdc Dental Corporation , Ltd.

K-Number K242404

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IYE 2025-02-07

Identify (4.0)

Applicant Varian Medical Systems, Inc.

K-Number K242957

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SAQ 2025-02-07

Symani Surgical System

Applicant Medical Microinstruments, Inc.

K-Number K242368

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HRS 2025-02-06

Signature Osteosynthesis Plate System

Applicant Signature Orthopaedic Pty , Ltd.

K-Number K241599

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NGL 2025-02-06

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K-Number K242428

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GEX 2025-02-06

Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)

Applicant Guangzhou Chuang Zao Mei Technology Co., Ltd.

K-Number K243465

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PKL 2025-02-06

Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)

Applicant Boston Scientific Corporation

K-Number K250066

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EOQ 2025-02-06

DUTAU-NOVATECH®

Applicant Novatech SA

K-Number K242324

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DQX 2025-02-06

CROSSLEAD 0.014inch

Applicant Asahi Intecc Co., Ltd.

K-Number K241702

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FRC 2025-02-06

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

Applicant STERIS Corporation

K-Number K250044

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