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

FDS 2022-02-03

Ambu® aScope™ Gastro, Ambu® aBox™2

Applicant Ambu A/S

K-Number K212382

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NHA 2022-02-03

Healing Abutment, Cover Screw

Applicant Megagen Implant Co., Ltd.

K-Number K210826

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DRG 2022-02-03

LifePath Remote Patient Monitoring Platform

Applicant Elastic Care Incorporated

K-Number K211822

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HWC 2022-02-03

MectaScrew Extension

Applicant Medacta International S.A.

K-Number K203335

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GEX 2022-02-02

Rosso

Applicant Quanta System Spa

K-Number K211228

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PMN 2022-02-02

NATtrol BD MAX Vaginal Panel External Controls

Applicant Zeptometrix

K-Number K201403

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LOD 2022-02-02

PALACOS MV pro

Applicant Heraeus Medical GmbH

K-Number K213812

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ELC 2022-02-02

EVOCLEAN CLEANsert Ultrasonic Insert

Applicant Ttbio Corp.

K-Number K210832

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GEX 2022-02-02

Sentient Manufacturing Laser Fiber

Applicant Sentient Manufacturing , LLC

K-Number K213554

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LPL 2022-02-02

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K-Number K211603

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KNW 2022-02-02

TeesuVac Breast Biopsy Device Mark 1

Applicant Teesuvac Aps

K-Number K212079

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OTZ 2022-02-02

EndoSerter-PL

Applicant Corneagen, Inc.

K-Number K203586

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