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

HWC 2021-06-01

Arthrex Beveled FT Screws

Applicant Arthrex, Inc.

K-Number K210994

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GXY 2021-06-01

Well-Life Garment Electrodes (GM Series)

Applicant Well-Life Healthcare Limited

K-Number K200942

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FED 2021-05-28

Pathfinder Endoscope Overtube

Applicant Neptune Medical, Inc.

K-Number K211301

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LPN 2021-05-28

ABT12 multi-purpose solution

Applicant Bausch & Lomb, Incorporated

K-Number K202932

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FBK 2021-05-28

Single Use Injection Needle

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K210917

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LPH 2021-05-28

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters

Applicant Waldemar Link GmbH & Co. KG

K-Number K200607

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MXD 2021-05-28

LINQ II Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K211304

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OCL 2021-05-28

AtriCure Isolator® Synergy Surgical Ablation System

Applicant AtriCure, Inc.

K-Number K211311

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HCG 2021-05-28

MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems

Applicant Medos International SARL

K-Number K211344

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LQK 2021-05-28

INVU by Nuvo

Applicant Nuvo- Group , Ltd.

K-Number K210025

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DQK 2021-05-28

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

Applicant Edwards Lifesciences, LLC

K-Number K203687

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DQY 2021-05-28

coraCross

Applicant Reflow Medical

K-Number K210188

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