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

HWC 2019-04-17

Arthrex 2.5 mm Tenodesis Screw

Applicant Arthrex, Inc.

K-Number K183395

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CGS 2019-04-17

SEKURE Creatine Kinase Assay

Applicant Sekisui Diagnostics P.E.I., Inc.

K-Number K182702

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MWI 2019-04-17

Stasis Monitoring System

Applicant Stasis Labs, Inc.

K-Number K183634

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DQD 2019-04-17

eMurmur ID

Applicant Csd Labs GmbH

K-Number K181988

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NHA 2019-04-17

Straumann BLX Variobase Abutment

Applicant Institut Straumann AG

K-Number K190082

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DHR 2019-04-17

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

Applicant Inova Diagnostics, Inc.

K-Number K190088

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OCX 2019-04-17

Andorate Auxiliary Water Connector

Applicant Smartdata Suzhou Co., Ltd.

K-Number K182998

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NUC 2019-04-16

KY Banksy Aloe

Applicant Rb Health (Us), LLC

K-Number K183302

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GDW 2019-04-16

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use

Applicant Ezisurg (Suzhou) Medical Co., Ltd.

K-Number K182217

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FAE 2019-04-16

Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

Applicant Boston Scientific Corporation

K-Number K183619

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JAQ 2019-04-16

BRAXX Esophageal Brachytherapy Applicator

Applicant Braxx Biotech Co., Ltd.

K-Number K183332

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JLW 2019-04-16

Elecsys TSH

Applicant Roche Diagnostics

K-Number K190773

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