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

MAX 2020-10-13

Zavation IBF System

Applicant Zavation Medical Products, LLC

K-Number K202305

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LZC 2020-10-11

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

Applicant 0 & M Halyard, Inc.

K-Number K200633

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JAK 2020-10-11

syngo.CT Neuro Perfusion

Applicant Siemens Medical Solutions USA, Inc.

K-Number K202213

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MQB 2020-10-11

Yushan X-Ray Flat Panel Detector with DROC

Applicant Innocare Optoelectronics Corp.

K-Number K201528

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IYN 2020-10-11

Voluson SWIFT, Voluson SWIFT+

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K201828

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LLZ 2020-10-11

Quantib Prostate

Applicant Quantib B.V.

K-Number K202501

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DQD 2020-10-09

Stethee Pro 1, Stethee Pro Software System

Applicant M3Dicine Pty , Ltd.

K-Number K193631

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HRX 2020-10-09

Zeos Aqua Vision Pump and tube

Applicant Hemodia Sas

K-Number K192921

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LIT 2020-10-09

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter

Applicant Cordis Corporation

K-Number K201377

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DXN 2020-10-09

V20, V20a, AVSM3 SNF

Applicant Mediana Co., Ltd.

K-Number K200434

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FGE 2020-10-09

BIOTEQ Drainage Catheter Set (One Step Type)

Applicant Bioteque Corporation

K-Number K200103

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PGW 2020-10-09

Instrument Clamps Electromagnetic

Applicant Stryker Corporation

K-Number K202609

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