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

DRA 2019-05-29

MitraClip G4 Steerable Guide Catheter

Applicant Abbott

K-Number K190167

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FED 2019-05-29

Peel-Away Introducer

Applicant Cook Incorporated

K-Number K182403

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JAK 2019-05-29

Brain Perfusion (BP) application

Applicant Philips Medical Systems Nederland B.V.

K-Number K182716

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ESW 2019-05-29

Segmented Esophageal Stent System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K182910

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OVD 2019-05-29

Juliet® Ti LL Lumbar Interbody Device

Applicant Spineart

K-Number K190877

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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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