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

CCK 2022-04-12

CARESCAPE CO2 Microstream parameter

Applicant Covidien, LLC

K-Number K213518

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KRD 2022-04-12

EMBOLD Fibered Detachable Coil System

Applicant Boston Scientific Corporation

K-Number K213398

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MAX 2022-04-12

Anteralign Spinal System with Titan nanoLOCK Surface Technology

Applicant Medtronic Sofamor Danek USA

K-Number K214010

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FYA 2022-04-12

Disposable Surgical Gown

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K-Number K214088

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HAW 2022-04-12

ClearPoint Array System (version 1.1)

Applicant ClearPoint Neuro, Inc.

K-Number K214040

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FRC 2022-04-12

Anprolene SteriTest RRBI

Applicant Andersen Sterilizers, Inc.

K-Number K213296

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PNZ 2022-04-12

Audion ET dilation system

Applicant Entellus Medical, Inc.

K-Number K220027

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GEX 2022-04-12

Finexel

Applicant SNJ Co., Ltd.

K-Number K213557

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MAX 2022-04-12

Ti3Z Lumbar Interbody System

Applicant Zavation Medical Products, LLC

K-Number K212811

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FMI 2022-04-12

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K214075

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KRA 2022-04-12

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter

Applicant Medos International SARL

K-Number K214025

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LZA 2022-04-11

Powder Free Nitrile Examination Glove, Non-sterile (Blue)

Applicant Ksg Medicare Sdn. Bhd.

K-Number K220209

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