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

JWH 2018-09-27

Acculoc Total Knee System

Applicant Rootloc Co., Ltd.

K-Number K182370

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KCT 2018-09-27

PureSet Tray

Applicant Nobel Biocare AB

K-Number K181075

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HRS 2018-09-27

CoLink View Plating System

Applicant In2bones USA, LLC

K-Number K182402

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JTN 2018-09-27

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K181975

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LZA 2018-09-26

Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K181066

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JTN 2018-09-26

HardyDisk AST Eravacycline 20µg (ERV20)

Applicant Hardy Diagnostics

K-Number K182357

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GEI 2018-09-26

InMode RF System

Applicant Inmode MD , Ltd.

K-Number K182325

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NUH 2018-09-26

Everyway Wireless TENS & EMS Unit

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K181707

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MAX 2018-09-26

Fixated Asfora BULLET CAGE® (FABC)

Applicant Medical Designs, LLC

K-Number K181591

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DQY 2018-09-26

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

Applicant Access Scientific, LLC

K-Number K181563

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CGA 2018-09-26

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K180340

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DQX 2018-09-26

Magic Torque DLVR Guidewire

Applicant Boston Scientific Corporation

K-Number K182315

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