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

BZD 2021-04-30

Innova Nasal Non-Vented Mask

Applicant Sleepnet Corporation

K-Number K203601

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QEW 2021-04-30

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24

Applicant Inari Medical, Inc.

K-Number K211013

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NKB 2021-04-30

CD Horizon™ Spinal System

Applicant Medtronic

K-Number K210637

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DPS 2021-04-30

MAC 7 - Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K203786

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KPS 2021-04-30

HYPER AiR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K210001

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FED 2021-04-30

Disposable Ureteral Access Sheath

Applicant Suzhou Beyo Medical Technology Co., Ltd.

K-Number K203165

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GEI 2021-04-30

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K203580

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MQB 2021-04-30

AcuityDRe

Applicant Radmedix, LLC

K-Number K210919

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JAK 2021-04-30

syngo. CT Extended Functionalities

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203699

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DQY 2021-04-30

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter

Applicant Vascular Solutions, LLC

K-Number K210647

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HRS 2021-04-30

JACE Medical Thoracic Plating System

Applicant Jace Medical, LLC

K-Number K210290

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MAX 2021-04-30

ProLift Lateral HELO Fixated

Applicant Life Spine, Inc.

K-Number K210061

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