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

JOJ 2026-02-20

LF Process Indicator Tape for Steam Sterilization

Applicant Intertape Polymer Group

K-Number K260181

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OLO 2026-02-19

VERTICALE GPS Instruments

Applicant Silony Medical GmbH

K-Number K254148

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QAI 2026-02-19

SkinStylus SteriLock MicroSystem (MP1209SL)

Applicant Esthetic Medical, Inc.

K-Number K253002

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KGN 2026-02-19

LacertaMatrix

Applicant Lacerta Life Sciences

K-Number K260218

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MUJ 2026-02-19

Monaco RTP System (6.3)

Applicant Elekta Solutions AB

K-Number K252002

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MUJ 2026-02-19

TrueFit Bolus

Applicant Adaptiiv Medical Technologies, Inc.

K-Number K260308

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DWF 2026-02-19

Retrograde Coronary Sinus Perfusion Cannulae

Applicant Medtronic, Inc.

K-Number K253203

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DYB 2026-02-19

AuST CSP Introducer

Applicant CenterPoint Systems, LLC

K-Number K260163

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FXX 2026-02-19

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Applicant Efofex, Inc.

K-Number K253398

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LLZ 2026-02-19

AS Software Version Asera

Applicant AS Software, LLC

K-Number K260205

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QNQ 2026-02-19

Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe

Applicant CMT Health PTE., Ltd.

K-Number K252814

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OLO 2026-02-19

Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor

Applicant Stryker Leibinger GmbH & Co KG

K-Number K253623

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