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

HBE 2021-11-23

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

Applicant Medtronic Powered Surgical Solutions

K-Number K213454

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PLP 2021-11-23

Exablate Prostate System

Applicant Insightec, Inc.

K-Number K212150

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QJP 2021-11-22

Spartan MC 0165

Applicant Spartan Micro

K-Number K213451

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DQX 2021-11-22

Pre-Formed Extra Support Guidewire

Applicant Lake Region Medical

K-Number K211741

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QLG 2021-11-22

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Applicant Abbott Diabetes Care, Inc.

K-Number K210943

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ESW 2021-11-22

Agile Esophageal OTW Stent System

Applicant Boston Scientific Corporation

K-Number K211960

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NUH 2021-11-22

Low-frequency Stimulator (Model: AST-645, AST-646)

Applicant Shenzhen Osto Technology Co., Ltd.

K-Number K212989

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OWN 2021-11-22

VS3 Iridium Sytem

Applicant Visionsense, Ltd.

K-Number K210265

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MWJ 2021-11-22

Eclipse PRO

Applicant Spacelabs Healthcare, Ltd.

K-Number K211651

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JAK 2021-11-22

Philips Incisive CT on Trailer

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K211168

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EBD 2021-11-22

VITA Akzent LC

Applicant Vita Zahnfabrik GmbH H Rauter & CO

K-Number K211854

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LZA 2021-11-22

Non-sterile Powder Free Nitrile Examination Gloves

Applicant Rubberex Alliance Sdn Bhd

K-Number K210990

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