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

OLO 2020-07-31

Navigation Enabled Intruments

Applicant Medos International SARL

K-Number K200791

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GEI 2020-07-31

BiPad Hand Activated, Disposable Bipolar Electrocautery Cords

Applicant Bipad Surgical, Inc.

K-Number K201833

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OMP 2020-07-31

Kendall NPWT Incision Management Dressing Kit

Applicant Cardinalhealth

K-Number K191101

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MTD 2020-07-31

Carto Octaray Mapping Catheter with Trueref Technology

Applicant Biosense Webster, Inc.

K-Number K193237

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PEW 2020-07-31

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge

Applicant Neotract, Inc.

K-Number K201837

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LAF 2020-07-31

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

Applicant Diatron Group

K-Number K201442

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LZO 2020-07-31

Cemented Origin Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K201951

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JAK 2020-07-31

Clear Guide SCENERGY

Applicant Clear Guide Medical

K-Number K201898

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BZH 2020-07-30

Safey Peak Flow Meter

Applicant Safey Medical Devices Pvt, Ltd.

K-Number K200832

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QLX 2020-07-30

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

Applicant Roche Molecular Systems, Inc.

K-Number DEN200015

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DQX 2020-07-30

HI-TORQUE PROCEED Guide Wire Family

Applicant Abbott Vascular

K-Number K201834

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QIH 2020-07-30

AI-Rad Companion Prostate MR

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193283

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