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

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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DYB 2019-05-30

FlexSeal Introducer Sheath with Hydrophilic Coating

Applicant Freudenberg Medical Mis, Inc.

K-Number K190628

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LFL 2019-05-30

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K-Number K190160

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QHA 2019-05-30

Qangio XA 3D

Applicant Medis Medical Imaging Systems BV

K-Number K182611

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LLZ 2019-05-30

ASHK100G

Applicant Lg Electronics

K-Number K191188

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JQC 2019-05-30

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

Applicant Emcyte Corporation

K-Number K183205

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