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

QWR 2025-04-11

cobas liat SARS-CoV-2 v2 nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K243346

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EIH 2025-04-11

Dental Zirconia Ceramic

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K250811

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HHW 2025-04-11

CooperSurgical Milex® Pessaries

Applicant CooperSurgical, Inc.

K-Number K250438

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ITI 2025-04-11

KLAXON (TWIST); KLAXON (TWIST R)

Applicant Klaxon-Mobility GmbH

K-Number K250748

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FGB 2025-04-11

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K243857

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QQE 2025-04-11

OTOPLAN

Applicant Cascination AG

K-Number K242120

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MYN 2025-04-11

Second Opinion Periapical Radiolucency Contours

Applicant Pearl, Inc.

K-Number K242600

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EBZ 2025-04-11

LED Curing Lights (DB686 HALO)

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K-Number K243921

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GEX 2025-04-11

Alma Harmony

Applicant Alma Lasers, Inc.

K-Number K243044

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NQQ 2025-04-11

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

Applicant Shenzhen Vivolight Medical Device & Technology Co., Ltd.

K-Number K242098

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NHA 2025-04-11

Atlantis® Abutments in Titanium

Applicant Dentsply Sirona

K-Number K250081

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EBI 2025-04-11

Asiga DentaBASE

Applicant Asiga Pty, Ltd.

K-Number K243356

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