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

IYN 2022-03-02

NovaGuide 2 Intelligent Ultrasound

Applicant Novasignal Corporation

K-Number K213279

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EIA 2022-03-02

A-dec 300, A-dec 500

Applicant A-Dec, Inc.

K-Number K213932

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HCH 2022-03-02

Sugita AVM Microclips

Applicant Mizuho America, Inc.

K-Number K211183

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FLE 2022-03-02

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

Applicant Fort Defiance Industries, LLC

K-Number K213457

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FMZ 2022-03-02

Giraffe Incubator Carestation CS1

Applicant Datex Ohmeda, Inc.

K-Number K213553

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FAS 2022-03-02

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

Applicant Chirurgie Innovation

K-Number K213135

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GEI 2022-03-02

ReNew Disposable Scissor Tips

Applicant Microline Surgical, Inc.

K-Number K213127

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OAS 2022-03-02

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Applicant Fona S.R.L

K-Number K213579

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KPL 2022-03-02

Bio Fluff System

Applicant Gnali Bocia S.R.L.

K-Number K201861

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FZP 2022-03-02

angioLOCK Polymer Ligating Clip

Applicant A2 Medical Systems, LLC

K-Number K220006

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FRN 2022-03-01

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

Applicant Fresenius Kabi AG

K-Number K210073

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KRD 2022-03-01

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

Applicant Artventive Medical Group, Inc.

K-Number K212057

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