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

KLE 2025-11-06

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA

Applicant Dmp Dental Industry S.A.

K-Number K252469

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QFG 2025-11-06

Tandem Mobi insulin pump with interoperable technology

Applicant Tandem Diabetes Care, Inc.

K-Number K253074

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KWS 2025-11-06

Catalyst F1x Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K252418

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HBE 2025-11-06

Hubly Drill (H100)

Applicant Hubly, Inc.

K-Number K250815

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IZF 2025-11-06

Adaptix Ortho350

Applicant Adaptix Limited

K-Number K252133

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QAS 2025-11-06

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K253265

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NGX 2025-11-06

Motive Muscle Stimulator for Lower Back (OT01-1003)

Applicant Motive Health, Inc.

K-Number K253478

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GEI 2025-11-06

Venus Nova (FP-2001)

Applicant Venus Concept, Inc.

K-Number K252845

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DXX 2025-11-06

Stereotaxis GenesisX RMN with Navigant Workstation (NWS)

Applicant Stereotaxis, Inc.

K-Number K251792

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OXO 2025-11-06

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

Applicant Hefei Chimed Intelligent Machine Co., Ltd.

K-Number K251004

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GEX 2025-11-06

Q-Switched Nd:Yag laser (K690)

Applicant Hebei Keylaser Sci-Tech Co.,Ltd

K-Number K252515

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OLO 2025-11-05

ExcelsiusGPS Instruments

Applicant Globus Medical, Inc.

K-Number K250599

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