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

LZA 2021-08-17

Disposable Medical Nitrile Gloves

Applicant Jiangsu Health-Peace Medical Technology Co., Ltd.

K-Number K211708

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LLZ 2021-08-17

Brain Perfusion (BP) application

Applicant Philips Medical Systems Nederland B.V.

K-Number K201573

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OBP 2021-08-17

Deep Transcranial Magnetic Stimulation (DTMS) System

Applicant Brainsway , Ltd.

K-Number K210201

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HDC 2021-08-17

ASPIVIX v1.1 Cervical Suction Tenaculum

Applicant Aspivix SA

K-Number K203820

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OAN 2021-08-17

STARband

Applicant Orthomerica Products, Inc.

K-Number K211376

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JWH 2021-08-16

CPM Medical Consultants Tibial Revision Knee System

Applicant Cpm Medical Consultants, LLC

K-Number K210695

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NRY 2021-08-16

Penumbra System (Reperfusion Catheter RED 72)

Applicant Penumbra, Inc.

K-Number K211654

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LZA 2021-08-16

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove

Applicant Rhino Health, Inc.

K-Number K203236

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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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