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

IYE 2019-08-06

The AIO Solution

Applicant Orfit Industries NV

K-Number K191158

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GXY 2019-08-05

EEG Electrode Template

Applicant Rhythmlink International, LLC

K-Number K191225

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OBR 2019-08-05

LunaGuard Nighttime Dental Protector

Applicant Mckeon Products

K-Number K191033

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DQY 2019-08-05

Crossing Support Catheter

Applicant Tractus Vascular, LLC

K-Number K183305

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LLZ 2019-08-05

aBSI

Applicant Exini Diagnostics AB

K-Number K191262

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DQA 2019-08-05

Beddr 200 System

Applicant Hancock Medical, Inc.

K-Number K190399

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LON 2019-08-05

VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)

Applicant bioMerieux, Inc.

K-Number K191766

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EYB 2019-08-05

UPJ Occlusion Balloon Catheter

Applicant Cook Incorporated

K-Number K183323

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FKH 2019-08-05

TDS Standard Solution

Applicant Mesa Laboratories, Inc.

K-Number K191496

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NHA 2019-08-05

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

Applicant Prismatik Dentalcraft, Inc.

K-Number K191222

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JAA 2019-08-05

FLUOROspeed

Applicant Shimadzu Corporation

K-Number K191877

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DYB 2019-08-02

Epicardial Access System

Applicant Baylis Medical Company, Inc.

K-Number K191546

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