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

KCT 2022-03-02

Southern Implants Instrument Trays

Applicant Southern Implants (Pty), Ltd.

K-Number K210923

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DFH 2022-03-02

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K212379

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MUH 2022-03-02

Dental Image Plate Scanner, Model DFC-4T-SMART

Applicant Hefei Dentafilm Medical Equipment Co., Ltd.

K-Number K214091

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MEG 2022-03-02

Sterile Syringe with Fixed Safety Needle for Single Use

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K212652

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FXX 2022-03-02

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

Applicant Medtecs (Taiwan) Corp.

K-Number K203376

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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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