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

INI 2021-02-10

Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K191897

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LOL 2021-02-09

LIAISON Anti-HAV

Applicant DiaSorin, Inc.

K-Number K210272

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GWO 2021-02-09

Stryker PEEK Customized Cranial Implant Kit

Applicant Stryker

K-Number K203055

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LLZ 2021-02-09

Synapse 3D, Synapse 3D Base Tools v6.1

Applicant Fujifilm Corporation

K-Number K203103

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OWB 2021-02-09

SmartCT R1.0

Applicant Philips Medical Systems Nederland B.V.

K-Number K201583

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FXX 2021-02-09

nPro Surgical Mask

Applicant Np Medical, Inc.

K-Number K203265

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GXY 2021-02-09

MR Conditional Sticky Pad Electrode

Applicant Rhythmlink International, LLC

K-Number K203079

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KRD 2021-02-09

Concerto Versa, Detachable Coil

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K202850

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QEW 2021-02-09

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

Applicant Penumbra, Inc.

K-Number K210083

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FOZ 2021-02-08

HydroMID

Applicant Access Vascular, Inc.

K-Number K203069

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DZE 2021-02-08

Straumann 4 mm Short Implants

Applicant Straumann USA, LLC

K-Number K202942

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MWI 2021-02-06

MouthLab Vital Signs Monitoring System

Applicant Multisensor Diagnostics (Dba Aidar Health)

K-Number K201635

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