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

GEI 2020-03-02

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

Applicant Covidien, LLC

K-Number K193356

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CAW 2020-02-29

Kingon P2 Oxygen Concentrator

Applicant Qingdao Kingon Medical Science and Technology Co.

K-Number K190304

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QFM 2020-02-28

Red Dot

Applicant Behold.Ai Technologies Limited

K-Number K191556

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KGO 2020-02-28

SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K192820

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QJS 2020-02-28

Basal-IQ Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K193483

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KGN 2020-02-28

scaffolene CL100 Bioresorbable Collagen Matrix

Applicant Freudenberg Technology Innovation SE & Co. KG

K-Number K192346

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LFL 2020-02-28

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length

Applicant Ethicon Endo-Surgery, LLC

K-Number K191555

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IRP 2020-02-28

Therm-X

Applicant Zenith Technical Innovations

K-Number K193550

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JKA 2020-02-28

Steripath Gen2 Blood Collection System

Applicant Magnolia Medical Technologies, Inc.

K-Number K192247

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LNH 2020-02-28

Magnetom Sola, Magnetom Altea and Magnetom Sola Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192496

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OWN 2020-02-28

Cellvizio I.V.E. with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K193416

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JDO 2020-02-28

CONQUEST FN

Applicant Smith & Nephew, Inc.

K-Number K193029

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