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

PKC 2020-07-08

Arthrex Eclipse Shoulder Prosthesis System

Applicant Arthrex, Inc.

K-Number K201542

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EBG 2020-07-08

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

Applicant Zirkonzahn Srl

K-Number K200676

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OMP 2020-07-08

ACTIV.A.C. Negative Pressure Wound Therapy System

Applicant Kci USA, Inc.

K-Number K201571

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EBF 2020-07-08

VisCalor

Applicant Voco GmbH

K-Number K201307

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DXZ 2020-07-08

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

Applicant Vascutek, Ltd.

K-Number K200955

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QEW 2020-07-08

CAPERE Thrombectomy System

Applicant Vascular Medcure, Inc.

K-Number K201216

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GCJ 2020-07-08

Looking Glass 4K Integrated Visualization System

Applicant Conmed Corporation

K-Number K201593

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GAM 2020-07-07

REXSIN

Applicant Sm Eng Co., Ltd.

K-Number K200392

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LNH 2020-07-06

uMR570

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K201540

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HRS 2020-07-06

Arthrex MaxForce MTP Compression Plates and Screws

Applicant Arthrex, Inc.

K-Number K201235

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IYE 2020-07-06

Lollipop BiteBlock

Applicant Radtec Medical Devices, Inc.

K-Number K200652

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JAK 2020-07-06

Deep Recon

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K193073

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