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

GEI 2021-08-16

Disposable Monopolar Laparoscopic Shafts and Reusable Handles

Applicant Dannik, LLC

K-Number K210569

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PNZ 2021-08-16

NuVent Eustachian Tube Dilation Balloon

Applicant Medtronic Xomed, Inc.

K-Number K210841

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GXY 2021-08-16

Metallic Fabric Electrodes

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K202636

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DSA 2021-08-16

Multi-Link X2 ECG Cable and Leadwire System

Applicant Vyaire Medical, Inc.

K-Number K211294

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LLZ 2021-08-16

TruSPECT Radiological Image Processing Station

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K212230

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MEH 2021-08-16

Insignia Hip Stem

Applicant Stryker Orthopaedics

K-Number K211703

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NKB 2021-08-16

Adena-Zina System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K212066

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DQK 2021-08-16

iMap 3D Mapping & Navigation System (iMap System)

Applicant Cardionxt, Inc.

K-Number K201094

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FPA 2021-08-14

I.V. Administration Set

Applicant Bq Plus Medical Co., Ltd.

K-Number K210381

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FTL 2021-08-13

Pitch-Patchs

Applicant Xiros, Ltd.

K-Number K211563

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LCX 2021-08-13

Clearblue® Early Digital Pregnancy Test

Applicant Spd Swiss Precision Diagnostics GmbH

K-Number K200913

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LZG 2021-08-13

Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

Applicant Insulet Corporation

K-Number K211575

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