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

JOJ 2020-12-02

WAVICIDE-OPA MEC Indicator

Applicant Serim Research Corporation

K-Number K202565

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LNH 2020-12-02

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K203053

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KCT 2020-12-02

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

Applicant K1 Medical, LLC

K-Number K202270

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OLO 2020-12-02

NuVasive Navigation.S Instruments

Applicant Nu Vasive, Incorporated

K-Number K200719

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LLZ 2020-12-02

Planmeca Romexis

Applicant Planmeca Oy

K-Number K200572

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KYI 2020-12-02

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

Applicant Ensemble Orthopedics, LLC

K-Number K201072

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LZA 2020-12-02

Palm Care Blue Nitrile Examination Gloves Powder Free

Applicant Hi-Care Thai Gloves Co. , Ltd.

K-Number K202384

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MCW 2020-12-02

Auryon Atherectomy System

Applicant Eximo Medical, Ltd.

K-Number K202835

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KPR 2020-12-01

Apolo D / Apolo S

Applicant Vmi Tecnologias Ltda

K-Number K202388

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DQK 2020-12-01

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K201015

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DZE 2020-12-01

Z5-TL

Applicant Z-Systems AG

K-Number K201712

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PKT 2020-12-01

SLIMUS

Applicant Hironic Co., Ltd.

K-Number K192970

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