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

BZQ 2025-03-28

Makani Science Respiration Monitoring System

Applicant Makani Science, Inc.

K-Number K233953

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KNT 2025-03-28

Flexi-Seal AIR (with ENFit Connector)

Applicant Convatec

K-Number K243228

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QQC 2025-03-28

Bullsai Confirm

Applicant Turing Medical Technologies, Inc.

K-Number K243520

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OWB 2025-03-28

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Applicant Medphoton GmbH

K-Number K234067

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KCT 2025-03-28

Synthes Graphic Case & Tray System

Applicant Synthes GmbH

K-Number K241927

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MBI 2025-03-28

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K250596

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JBQ 2025-03-28

INNOVANCE Antithrombin

Applicant Siemens Healthcare Diagnostic Products GmbH

K-Number K242952

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MBH 2025-03-27

iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System

Applicant Restor3D, Inc.

K-Number K243768

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DQX 2025-03-27

Crossloop

Applicant Asahi Intecc Co., Ltd.

K-Number K241962

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DYB 2025-03-27

Edwards eSheath Optima introducer set

Applicant Edwards Lifesciences

K-Number K244046

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FOZ 2025-03-27

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

Applicant Access Vascular, Inc.

K-Number K244059

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QKB 2025-03-27

AI-Rad Companion Organs RT

Applicant Siemens Healthcare GmbH

K-Number K242745

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