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

QIH 2021-06-10

syngo.via MI WorkFlows, Scenium, syngo MBF

Applicant Siemens Medical Solutions USA, Inc.

K-Number K211459

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BZG 2021-06-10

Spirometer

Applicant Mehow Innovative, Ltd.

K-Number K201493

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NUC 2021-06-10

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two

Applicant CC Wellness, LLC

K-Number K210972

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MBH 2021-06-10

Symmetric Total Knee System

Applicant Signal Medical Corporation

K-Number K203779

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IYN 2021-06-10

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K210416

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NUC 2021-06-10

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit

Applicant CC Wellness, LLC

K-Number K210986

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FXX 2021-06-10

Disposable Surgical Mask

Applicant Lucky Textile Industrial(Wuxi) Co., Ltd.

K-Number K203756

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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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