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

KPS 2021-09-16

Symbia VA10A Family

Applicant Siemens Medical Solutions USA, Inc.

K-Number K212604

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KIF 2021-09-16

BioRoot Flow 0.5g, BioRoot Flow 2g

Applicant Septodont

K-Number K212283

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LZA 2021-09-16

Blue Nitrile Examination Glove Powder Free

Applicant Aspen Glove Sdn. Bhd.

K-Number K211479

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JXG 2021-09-16

StrataMR II Valves and Shunts

Applicant Medtronic Neurosurgery

K-Number K212641

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JWH 2021-09-16

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

Applicant Waldemar Link GmbH & Co. KG

K-Number K212742

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DTZ 2021-09-16

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

Applicant Medtronic

K-Number K203111

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IYN 2021-09-16

6430 MyLabX75, 6430 MyLab XPro75

Applicant Esaote, S.p.A.

K-Number K212021

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HSX 2021-09-16

VISIONAIRE UK Patient Matched Cutting Guides

Applicant Smith & Nephew, Inc.

K-Number K211512

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KGO 2021-09-16

Sterile Latex Surgical Gloves Powder Free

Applicant Aspen Glove Sdn. Bhd.

K-Number K211478

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NLH 2021-09-15

Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters

Applicant Innovative Health, LLC

K-Number K211276

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MUH 2021-09-15

RXS 1000

Applicant Rolence Enterprise, Inc.

K-Number K202369

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HIH 2021-09-15

HTx Disposable Hysteroscope System

Applicant Acuvu, Inc.

K-Number K211227

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