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

MAX 2019-06-28

TxTi IBF System

Applicant Innovasis, Inc.

K-Number K183064

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KGO 2019-06-28

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove

Applicant Hartalega NGC Sdn. Bhd.

K-Number K183389

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DSP 2019-06-28

UltraFlex IAB

Applicant Arrow International, Inc.

K-Number K190101

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QBJ 2019-06-28

Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K191450

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JEY 2019-06-28

Stryker Surgeon iD Mandible Recon Plate

Applicant Stryker

K-Number K190696

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NKA 2019-06-28

SureTouch Mobile Pressure Mapping System

Applicant Sure, Inc.

K-Number K181672

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PEN 2019-06-28

iC-GN iC-Cassette for use on the iC-System

Applicant Icubate, Inc.

K-Number K190341

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OLO 2019-06-28

NAVIO

Applicant Blue Belt Technologies, Inc.

K-Number K191223

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DQY 2019-06-28

Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4

Applicant Centerpoint Systems

K-Number K190475

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HTN 2019-06-28

MicroLink All-Suture Button Fixation System (Radiolucent)

Applicant Conmed Corporation

K-Number K190516

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LZA 2019-06-27

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K190080

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CFN 2019-06-27

Human IgM Kit for use on SPAPlus

Applicant The Binding Site Group , Ltd.

K-Number K191465

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