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

DXG 2021-11-23

Hypotension Decision Assist Model HDA-OR2

Applicant Directed Systems, Ltd.

K-Number K212529

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IRP 2021-11-23

Air compression therapy system FO3002

Applicant Foshan Hongfeng Co., Ltd.

K-Number K212169

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LQP 2021-11-23

Sofia 2 Campylobacter FIA

Applicant Quidel Corporation

K-Number K211342

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HIH 2021-11-23

Hystero-V Hysteroscope

Applicant Hysterovue, Inc.

K-Number K202445

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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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QRC 2021-11-23

vPatch

Applicant Virility Medical

K-Number DEN210012

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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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