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

PTI 2023-06-08

Promisemed Safety Huber Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K230715

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MBI 2023-06-07

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

Applicant Suzhou Endophix Co., Ltd.

K-Number K231002

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OUR 2023-06-07

TiLink-L SI Joint Fusion System

Applicant SurGenTec, LLC

K-Number K230446

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FLL 2023-06-07

Infrared Thermometer

Applicant Alicn Medical Shenzhen, Inc.

K-Number K222248

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JPA 2023-06-07

STA R Max 3, STA Compact Max 3

Applicant Diagnostica Stago S.A.S

K-Number K212183

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LLZ 2023-06-07

Ambra PACS

Applicant Dicom Grid Dba Ambra Health

K-Number K231360

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KWS 2023-06-07

AETOS Shoulder System

Applicant Smith & Nephew, Inc.

K-Number K230572

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NQQ 2023-06-07

HyperVue Imaging System

Applicant Spectrawave, Inc.

K-Number K230691

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HDX 2023-06-07

Intimate Rose Vaginal Dilators

Applicant Plus EV Holdings Dba Intimate Rose

K-Number K231430

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MXA 2023-06-07

Fenom Pro

Applicant Caire Diagnostics, Inc.

K-Number K213611

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JTN 2023-06-07

BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)

Applicant Becton, Dickinson and Company

K-Number K230651

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MBI 2023-06-07

Fix2Lock(PEEK Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K231322

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