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

DQK 2021-10-22

EnSite X EP System

Applicant Abbott

K-Number K212061

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FDF 2021-10-22

DiLumen C2 and Tool Mount

Applicant Lumendi, LLC

K-Number K211819

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KCT 2021-10-22

UroLift System Rigid Retrieval Kit Sterilization Tray

Applicant Neotract, Inc.

K-Number K212396

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HBE 2021-10-22

P300 Attachment

Applicant Nakanishi, Inc.

K-Number K202120

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MLR 2021-10-22

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

Applicant Plasmapp Co,., Ltd.

K-Number K212200

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NHN 2021-10-22

Erchonia XLR8

Applicant Erchonia Corporation

K-Number K211186

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MQC 2021-10-21

GR Splint Resin System

Applicant Pro3Dure Medical GmbH

K-Number K211415

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PMC 2021-10-21

Portable Scalp Cooling System

Applicant Cooler Heads Care, Inc.

K-Number K211526

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HWC 2021-10-21

Treace Medical Concepts (TMC) Screw Fixation System

Applicant Treace Medical Concepts, Inc.

K-Number K213036

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BTR 2021-10-21

Tenax Laser Resistant Endotracheal Tube

Applicant Bryan Medical, Inc.

K-Number K213028

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DQA 2021-10-21

Belun Ring BLR-100X

Applicant Belun Technology Company Limited

K-Number K211407

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OHT 2021-10-21

IPL Hair Removal Device

Applicant Zhongshan Bisen Plastic Electronic Products Co., Ltd.

K-Number K212314

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