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

MSX 2020-05-11

Critical Alert CommonPath Enterprise

Applicant Critical Alert

K-Number K193043

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FRO 2020-05-11

PuraDERM Gel

Applicant 3-D Matrix, Inc.

K-Number K193085

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MQV 2020-05-11

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)

Applicant SeaSpine Orthopedics Corporation

K-Number K200290

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GEI 2020-05-11

Thunderbeat Open Fine Jaw Type X Hand Instrument

Applicant Olympus Medical Systems Corp.

K-Number K192103

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NXC 2020-05-11

Arcad SmileStudio and Aligner System

Applicant Arcadlab

K-Number K192244

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GEI 2020-05-11

ArtiSential Laparoscopic Instrument-Electrodes

Applicant Livsmed, Inc.

K-Number K200501

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OJY 2020-05-11

NP Screen

Applicant Advance Sentry Corporation

K-Number DEN190031

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OUO 2020-05-11

Biograph mMR with syngo MR E11P-AP01 system software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200213

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GEI 2020-05-11

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11

Applicant Ethicon Endo-Surgery, LLC

K-Number K200841

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GEX 2020-05-09

Dermalux Tri-Wave MD

Applicant Aesthetic Technology, Ltd.

K-Number K200659

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HRS 2020-05-08

Treace Medical Concepts (TMC) Plating System

Applicant Treace Medical Concepts, Inc.

K-Number K200961

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JXG 2020-05-08

Ventricular Catheter

Applicant Aesculap, Inc.

K-Number K200950

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