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

BTT 2020-03-19

F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K191818

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DRE 2020-03-19

Super Sheath

Applicant Togo Medikit Co., Ltd.

K-Number K200379

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LOD 2020-03-19

G3 40 Radiopaque Bone Cement

Applicant G21, S.R.L.

K-Number K193061

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GAW 2020-03-19

Deklene MAXX

Applicant Teleflex Medical

K-Number K193530

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JOW 2020-03-19

Compression Therapy Device

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K191856

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FPA 2020-03-19

IV Sets not made with PVC

Applicant B.Braun Medical, Inc.

K-Number K191658

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KNS 2020-03-19

Creo Electrosurgical System with HS1 Hemostasis Accessory

Applicant Creo Medical, Ltd.

K-Number K192905

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QAS 2020-03-18

Viz ICH

Applicant Viz. Ai, Inc.

K-Number K193658

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NTE 2020-03-18

WIRION

Applicant Cardiovascular Systems, Inc.

K-Number K200198

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MAI 2020-03-18

HEALICOIL Knotless Suture Anchors

Applicant Smith & Nephew, Inc.

K-Number K193558

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BSZ 2020-03-18

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

Applicant Maquet Critical Care AB

K-Number K191027

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LTT 2020-03-18

MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K193536

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