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 2021-08-18

Surgical Face Mask

Applicant Macheng Thimble Technology Investment Co., Ltd.

K-Number K211631

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LLZ 2021-08-17

ROSA Hip System

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K210998

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JWH 2021-08-17

Journey II Mid-Level Tibial Inserts

Applicant Smith & Nephew, Inc.

K-Number K211671

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QDK 2021-08-17

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K203089

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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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