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

HKI 2026-06-22

TearView

Applicant Beyond 700 Pty, Ltd.

K-Number K253176

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NUC 2026-06-22

Flow Water-Based Personal Lubricant

Applicant LBDO Group, Inc.

K-Number K254011

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DYB 2026-06-22

Health Line Tearaway Introducer

Applicant Health Line International Corporation

K-Number K261950

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QKA 2026-06-22

Urocross Expander System (UES-2018-C1)

Applicant Prodeon Medical, Inc.

K-Number K261342

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OLO 2026-06-20

Dynamis Robotic Surgical System

Applicant LEM Surgical AG

K-Number K260369

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QVB 2026-06-18

InstaTRU Instant Biological Indicator for Steam (IBI-05)

Applicant True Indicating, LLC

K-Number K251559

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KCT 2026-06-18

SteriBest® Sterilization Tray System

Applicant Mastel Surgical

K-Number K253187

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QME 2026-06-18

SmartSpectra Vital Signs Monitor 1.0

Applicant Presage Security, Inc. d/b/a Presage Technologies, Inc.

K-Number K254169

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IYO 2026-06-18

ARTHUR

Applicant ROPCA ApS

K-Number K260190

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KPI 2026-06-18

Pelvic Muscle Trainer (KM510, KM516B)

Applicant Shenzhen Konmed Technology Co., Ltd.

K-Number K260178

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DZE 2026-06-18

MegaGen Zygoma Dental Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K251232

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HSB 2026-06-18

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

Applicant Suzhou and Science & Technology Development Corp.

K-Number K253080

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