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

FAD 2019-12-02

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip

Applicant Allwin Medical Devices, Inc.

K-Number K190659

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MQV 2019-11-30

Resorbable Mesh Device

Applicant SeaSpine Orthopedics Corporation

K-Number K193040

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LLL 2019-11-29

EliA SymphonyS Immunoassay

Applicant Phadia AB

K-Number K190710

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DQY 2019-11-29

AXS Infinity LS Plus Long Sheath

Applicant Stryker Neurovascular

K-Number K193034

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DQY 2019-11-29

ASAHI CROSSWALK Peripheral Support Catheter

Applicant Asahi Intecc Co., Ltd.

K-Number K192782

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OUK 2019-11-29

Innonix Antiviral Child's Face Mask

Applicant Innonix Technologies Limited

K-Number K192105

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GWN 2019-11-29

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph

Applicant Neurolign USA, LLC

K-Number K192186

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KWT 2019-11-29

Shoulder Innovations Total Shoulder System

Applicant Shoulder Innovations, Inc.

K-Number K192365

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LNH 2019-11-27

fMRI Hardware System

Applicant Nordicneurolab AS

K-Number K191032

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PNN 2019-11-27

3Shape Splint Design

Applicant 3Shape A/S

K-Number K191911

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DQK 2019-11-27

Rhythmia HDxTM Mapping System

Applicant Boston Scientific Corporation

K-Number K192438

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GBM 2019-11-27

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter

Applicant Hangzhou Bever Medical Devices Co., Ltd.

K-Number K192468

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