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

QMD 2021-04-16

Brainsway Deep (DTMS) System

Applicant Brainsway , Ltd.

K-Number K203616

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OAS 2021-04-16

rainbow CT

Applicant Dentium Co., Ltd (Ict Branch)

K-Number K200271

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DZE 2021-04-15

Locator Overdenture Implant System

Applicant Ivory Super Holdco Inc. / Zest Anchors, LLC

K-Number K203701

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NKB 2021-04-15

CoreLink Midline Fixation System

Applicant Corelink, LLC

K-Number K210539

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PCU 2021-04-15

AXIOS Stent and Electrocautery Enhanced Delivery System

Applicant Boston Scientific Corporation

K-Number K203132

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HIS 2021-04-15

SKORE (Colors & Flavors), SKORE (Colors)

Applicant Ttk Healthcare Limited

K-Number K202403

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QSY 2021-04-15

Axiostat Patch

Applicant Advamedica, Inc.

K-Number K202830

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PSY 2021-04-15

MDPC-8127

Applicant Barco N.V.

K-Number K203364

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DQX 2021-04-15

Verrata PLUS Pressure Guide Wire

Applicant Volcano Corporation

K-Number K210235

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GEI 2021-04-15

Edge Insulated Blade Electrode

Applicant Covidien, LLC

K-Number K210338

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KRA 2021-04-15

Instylla Microcatheter 1.2

Applicant Instylla, Inc.

K-Number K210808

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KWS 2021-04-15

BLUEPRINT™ Patient Specific Instrumentation

Applicant Tornier S.A.S.

K-Number K203315

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