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

EMA 2019-05-29

3M RelyX Pediatric Resin Modified Glass Ionomer Cement

Applicant 3M Espe Dental Products

K-Number K191122

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IOR 2019-05-29

Manual Wheelchair SIVFH2A102

Applicant Jiangsu Horizon Medical Science & Technology Co., Ltd.

K-Number K190534

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KTT 2019-05-29

Revolution External Plating System

Applicant New Standard Device Dba Metalogix

K-Number K181630

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JWY 2019-05-29

MTS Doxycycline 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K190914

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KIF 2019-05-29

GuttaSil

Applicant Meta Biomed Co., Ltd.

K-Number K190510

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MWI 2019-05-28

Nihon Kohden SVM-7200 Series Vital Signs Monitor

Applicant Nihon Kohden Corporation

K-Number K190468

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CFN 2019-05-28

Optilite IgM CSF Kit

Applicant The Binding Site Group , Ltd.

K-Number K190686

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LZA 2019-05-28

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile

Applicant Kossan International Sdn Bhd

K-Number K190606

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MBI 2019-05-28

MectaLock PEEK Suture Anchor

Applicant Medacta International S.A.

K-Number K190474

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NKB 2019-05-28

AccelFix Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K182544

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FPA 2019-05-28

Clearlink System Solution Set

Applicant Baxter Healthcare Corporation

K-Number K180739

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MQV 2019-05-28

IGNITE Bone Void Filler

Applicant Wrightmedicaltechnologyinc

K-Number K190482

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