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

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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LPH 2019-05-31

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling

Applicant Zimmer, Inc.

K-Number K182678

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LZA 2019-05-30

Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs

Applicant Sri Trang Gloves (Thailand) Co., Ltd.

K-Number K182308

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OCL 2019-05-30

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

Applicant Medtronic

K-Number K190623

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FED 2019-05-30

Arc Endocuff Glide AEG110 & AEG120

Applicant Boddingtons Plastics, Ltd.

K-Number K191067

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IRP 2019-05-30

Air Relax

Applicant Maxstar Industrial Co., Ltd.

K-Number K173158

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LZO 2019-05-30

MasterLoc Extension

Applicant Medacta International S.A.

K-Number K191145

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DRB 2019-05-30

GaltTWS

Applicant Galt Medical Corp.

K-Number K182660

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