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

KIF 2024-01-26

One-Fil

Applicant Mediclus Co., Ltd.

K-Number K232182

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OUR 2024-01-26

iFuse Bedrock Granite® Implant System

Applicant SI-BONE, Inc.

K-Number K233508

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GEI 2024-01-25

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

Applicant Sutter Medizintechnik GmbH

K-Number K233425

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KWQ 2024-01-25

ADIRA™ Lateral Plate System

Applicant Globus Medical, Inc.

K-Number K233735

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EZD 2024-01-25

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

Applicant Convatec

K-Number K232665

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MBI 2024-01-25

AlphaVent Knotless SP PEEK Anchor

Applicant Stryker Endoscopy

K-Number K233893

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HQF 2024-01-25

MR Q; MR Q SUPINE; MR Q SLT

Applicant Meridian AG

K-Number K232417

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LPL 2024-01-25

Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker

Applicant CooperVision, Inc.

K-Number K234127

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LLZ 2024-01-25

BreView

Applicant GE Medical Systems SCS

K-Number K233714

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QRL 2024-01-25

Facet Aurora Reusable Lancet Base

Applicant Facet Technologies, LLC

K-Number K232912

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LLZ 2024-01-24

Axial3D Cloud Segmentation Service

Applicant Axial Medical Printing Limited

K-Number K231607

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IYN 2024-01-24

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

Applicant Canon Medical Systems Corporation

K-Number K233195

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