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

QAS 2019-05-31

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K190896

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GEH 2019-05-31

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Applicant Pentax Medical, A Division of Pentax of America, Inc.

K-Number K190194

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OVE 2019-05-31

NEXXT MATRIXX Stand Alone Cervical System

Applicant Nexxt Spine, LLC

K-Number K190546

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FRO 2019-05-31

Apis

Applicant Sweetbio, Inc.

K-Number K182725

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LNH 2019-05-31

MAGNETOM Avanto Fit

Applicant Siemens Medical Solution USA, Inc.

K-Number K190757

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LOD 2019-05-31

PALACOS fast R+G

Applicant Heraeus Medical GmbH

K-Number K190766

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MMK 2019-05-31

Tiger Sharps Containers

Applicant International Marketing Specialists, Inc.

K-Number K190240

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PIF 2019-05-31

U Deliver Bolink ENFit Enteral Feeding Sets

Applicant U Deliver Medical, LLC

K-Number K190310

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MSD 2019-05-31

Pristine Hemodialysis Catheter

Applicant Pristine Access Technologies , Ltd.

K-Number K182443

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GCJ 2019-05-31

E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K190831

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KWD 2019-05-31

Cannulated Hemi Implant

Applicant Vilex IN Tennessee, Inc.

K-Number K190543

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JXI 2019-05-31

NeuroShield

Applicant Monarch Bioimplants GmbH

K-Number K190246

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