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

ETN 2022-11-11

Mapping Suction Probe

Applicant Inomed Medizintechnik GmbH

K-Number K212164

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EBI 2022-11-10

SprintRay High Impact Denture Base

Applicant Sprintray, Inc.

K-Number K221678

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GCJ 2022-11-10

H1

Applicant Karl Storz Endoscopy America, Inc.

K-Number K222504

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GYC 2022-11-10

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

Applicant Spes Medica Srl

K-Number K211954

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JEY 2022-11-10

Tandry CMF Plate System

Applicant Microware Precision Co., Ltd.

K-Number K220360

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QPZ 2022-11-10

Dermal Cooling System

Applicant R2 Technologies, Inc.

K-Number K213294

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MSQ 2022-11-10

BreathID® Smart System

Applicant Meridian Bioscience Israel , Ltd.

K-Number K223185

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FXX 2022-11-10

Humask Pro Vision, Humask Pro Vision 3000

Applicant Entreprise Premont, Inc.

K-Number K222551

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LLZ 2022-11-10

Synapse 3D Base Tools v6.6

Applicant Fujifilm Corporation

K-Number K221677

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JLW 2022-11-10

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

Applicant Beckman Coulter, Inc.

K-Number K221225

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PIB 2022-11-10

AEYE-DS

Applicant Aeye Health, Inc.

K-Number K221183

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LZH 2022-11-10

AMSure Enteral Feeding Pump

Applicant Amsino International, Inc.

K-Number K220230

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