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

MAX 2021-09-29

DualX

Applicant Amplify Surgical, Inc.

K-Number K211740

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NAY 2021-09-29

Da Vinci SP Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K212747

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LXB 2021-09-29

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

Applicant Cochlear Americas

K-Number K212136

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OVD 2021-09-29

Axis Spine Technologies ALIF

Applicant Axis Spine Technologies, Ltd.

K-Number K210590

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FXX 2021-09-29

UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2

Applicant Universal Incorporation

K-Number K210513

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QQO 2021-09-28

SoftSpot

Applicant Pediametrix, Inc.

K-Number K212045

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KPS 2021-09-28

SubtlePET

Applicant Subtle Medical, Inc.

K-Number K211964

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LLZ 2021-09-28

EzDent Web

Applicant Ewoosoft Co., Ltd.

K-Number K211700

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QCC 2021-09-28

Advisor Pro Platform

Applicant DreaMed Diabetes, Ltd.

K-Number K210561

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FXX 2021-09-28

Surgical Face Mask (Model: CM2006, CM2008, A88)

Applicant Shenzhen Realtone Medical Appliance Co., Ltd.

K-Number K210878

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FXX 2021-09-28

Disposable surgical mask

Applicant Shanghai No.9 Knitting Mill Co., Ltd.

K-Number K211794

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IYE 2021-09-28

Panther OIS

Applicant Prowess, Inc.

K-Number K211760

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