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

QDB 2021-10-22

IRNF App

Applicant Apple, Inc.

K-Number K212516

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OUP 2021-10-22

Aveli

Applicant Nc8, Inc.

K-Number K212399

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LLZ 2021-10-22

FlightPlan for Liver

Applicant GE Medical Systems SCS

K-Number K210807

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KWQ 2021-10-22

Quantum Anterior Cervical Plate

Applicant Nvision Biomedical Technologies, Inc.

K-Number K210424

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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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