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

DTE 2025-01-10

Solo Pace Control

Applicant Solo Pace, Inc.

K-Number K241781

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QWO 2025-01-10

ScreenDx

Applicant Imvaria, Inc.

K-Number K241891

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ITI 2025-01-10

Klaxon (Twist); Klaxon (Twist R)

Applicant Klaxon Mobility GmbH

K-Number K240267

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EMA 2025-01-10

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

Applicant Overfibers S.R.L.

K-Number K242366

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HEB 2025-01-10

Unscented Tampon

Applicant Shandong Intco Hygiene Products Co., Ltd.

K-Number K241064

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JMT 2025-01-10

Safecare Urinary Tract Infection Test

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K242767

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HGM 2025-01-10

PeriCALM Patterns 3.0

Applicant Perigen, Inc.

K-Number K241009

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JAQ 2025-01-10

Mould Probe MR Safe

Applicant Varian Medical Systems, Inc.

K-Number K241764

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QKQ 2025-01-09

FullFocus

Applicant Paige.Ai, Inc.

K-Number K241273

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OAS 2025-01-09

Dental Cone-beam Computed Tomography (FinScan F350)

Applicant Changzhou Finno Medical Technology Co., Ltd.

K-Number K242805

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PCH 2025-01-08

QIAstat-Dx GI Panel 2 Mini B&V

Applicant QIAGEN GmbH

K-Number K243813

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LZA 2025-01-08

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K243818

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