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

JDR 2024-09-06

TMC Compression Implant System

Applicant Treace Medical Concepts

K-Number K242415

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LHI 2024-09-06

nextaro® va, 15mm, 5µm

Applicant Sfm Medical Devices GmbH

K-Number K241976

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LLZ 2024-09-05

TRAQinform IQ

Applicant Aiq Global, Inc.

K-Number K233998

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OUK 2024-09-05

ProGear® Surgical Mask with Oxafence®, Model AV82030

Applicant Prestige Ameritech

K-Number K231741

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FRN 2024-09-05

Novum IQ Syringe Pump (40800BAXUS)

Applicant Baxter Healthcare Corporation

K-Number K242390

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INI 2024-09-05

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)

Applicant Intradin (Shanghai) Machinery Co., Ltd.

K-Number K232692

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ITI 2024-09-05

Electric wheelchair (W3902)

Applicant Zhejiang Richall Medical Technology Co., Ltd.

K-Number K241723

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FGB 2024-09-05

URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)

Applicant Dyne Medical Group, Inc.

K-Number K240203

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MAX 2024-09-05

Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology

Applicant Nanovis, LLC

K-Number K241605

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HRS 2024-09-05

Fine Osteotomy™

Applicant Bodycad Laboratories, Inc.

K-Number K241356

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DZE 2024-09-05

ICX-Implant System

Applicant Medentis Medical GmbH

K-Number K231566

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OKJ 2024-09-05

Cold Sore Device (QPZ-03)

Applicant Shenzhen Nuon Medical Equipment Co., Ltd.

K-Number K241155

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