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

FMI 2024-07-02

ZIEN IO Intraosseous Access System

Applicant Zien Medical Technologies, Inc.

K-Number K240915

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JAQ 2024-07-02

AOS Marker Seeds (SMG0242-025)

Applicant Alpha-Omega Services, Inc.

K-Number K233626

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OUR 2024-07-02

iFuse TORQ® Implant System

Applicant SI-BONE, Inc.

K-Number K241574

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BZD 2024-07-02

DELTAWAVE Nasal Pillows System

Applicant Remsleep Holdings

K-Number K233415

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PHZ 2024-07-02

Tyto Insights for Crackles Detection

Applicant Tyto Care , Ltd.

K-Number K240555

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LZG 2024-07-02

Extended Reservoir; MiniMed Reservoir

Applicant Medtronic Minimed

K-Number K241622

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QIH 2024-07-02

SMART Bun-Yo-Matic X-Ray

Applicant Disior, Ltd.

K-Number K240736

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LLZ 2024-07-02

ViewPoint 6

Applicant Ge Healthcare GmbH

K-Number K241300

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LZA 2024-07-02

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue

Applicant Sri Trang Gloves Thailand (Public Company Limited)

K-Number K240930

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NRY 2024-07-02

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

Applicant Balt USA, LLC

K-Number K234083

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HGM 2024-07-02

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K233440

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QJP 2024-07-02

Next Generation Access Catheter

Applicant Balt USA, LLC

K-Number K234074

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