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

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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LBI 2021-05-28

Infant Phototherapy Equipment

Applicant Bistos Co., Ltd.

K-Number K210289

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FQH 2021-05-28

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K-Number K210536

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HWC 2021-05-28

Axis Charcot Fixation System

Applicant Extremity Medical, LLC

K-Number K211261

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OWI 2021-05-27

LigaPASS® Spinal System, CD Horizon™ Spinal System

Applicant Medtronic, Inc.

K-Number K211057

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KNS 2021-05-27

Aqua Medical RF Vapor System

Applicant Aqua Medical, Inc.

K-Number K211282

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NWJ 2021-05-27

GalaSTITCH Absorbable Monofilament Suture

Applicant Tepha, Inc.

K-Number K211307

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