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

NIE 2023-01-13

Power Acute Triple Lumen Hemodialysis Catheter

Applicant Health Line International Corporation

K-Number K222170

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EZL 2023-01-13

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F

Applicant Potrero Medical, Inc.

K-Number K221020

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MAX 2023-01-13

PathLoc-TA Expandable Lumbar Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K223474

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HBI 2023-01-13

Light-Guide Cables

Applicant Olympus Winter & Ibe GmbH

K-Number K223183

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PLR 2023-01-13

Galileo Vertebral Body Replacement Device

Applicant Bright Spine

K-Number K221542

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OBP 2023-01-13

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+

Applicant Magstim Company, Ltd.

K-Number K222171

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DZE 2023-01-13

S-Mono

Applicant Shinhung Mst Co., Ltd.

K-Number K221317

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NHA 2023-01-13

s-Clean Link Abutment

Applicant Dentis Co., Ltd.

K-Number K222913

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QTN 2023-01-13

Vibrant System

Applicant Vibrant, Ltd.

K-Number K223031

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LZA 2023-01-13

Non-Sterile Powder Free Nitrile Examination Gloves

Applicant Dynacare Sdn Bhd

K-Number K223221

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FXX 2023-01-13

Ideal Med Pro 3-Ply Disposable Face Mask

Applicant Jsn Holdings, LLC

K-Number K221682

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MEH 2023-01-13

SignaSure Dual Mobility System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K220495

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