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

FXX 2021-06-10

Surgical Masks, Model:FE-1

Applicant Hunan Triplex Precision Medical Devices Co., Ltd.

K-Number K210767

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QEY 2021-06-10

BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)

Applicant Thrombolex, Inc.

K-Number K211061

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FXX 2021-06-10

Surgical Face Mask

Applicant Sample King Manufacturing, Ltd.

K-Number K210015

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BRZ 2021-06-10

Blood Administration Set

Applicant Baxter Healthcare Corporation

K-Number K210335

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PIB 2021-06-10

IDx-DR

Applicant Digital Diagnostics, Inc.

K-Number K203629

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OLO 2021-06-09

Navigated Anterolateral Disc Prep Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K211441

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IYO 2021-06-09

Palm Bladder Scanner - PBSV7.1

Applicant Mianyang Meike Electronic Equipment Co., Ltd.

K-Number K210591

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IYN 2021-06-09

Vivid S60N / Vivid S70N

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K211216

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ERL 2021-06-09

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

Applicant Stryker Corporation

K-Number K211490

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JDI 2021-06-09

ELEOS Limb Salvage System with BioGrip

Applicant Onkos Surgical

K-Number K203815

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FXX 2021-06-08

Disposable Surgical Mask

Applicant Shenzhen Peninsula Medical Co., Ltd.

K-Number K202126

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NRY 2021-06-08

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing

Applicant Imperative Care, Inc.

K-Number K211476

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