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

GCJ 2018-07-27

Universal Cannula Seal (5-12 mm)

Applicant Intuitive Surgical, Inc.

K-Number K181395

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QEW 2018-07-27

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical

K-Number K181694

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FDS 2018-07-27

FUJIFILM Ultrasonic Endoscope

Applicant Fujifilm Corporation

K-Number K181763

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MAX 2018-07-27

Ti 3Z Interbody System

Applicant Zavation Medical Products, LLC

K-Number K180076

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DQA 2018-07-27

Pulse Oximeter

Applicant Beijing Safe Heart Technology , Ltd.

K-Number K172616

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OAS 2018-07-27

RCT800

Applicant Ray Co., Ltd.

K-Number K181452

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MAX 2018-07-27

Corelink Foundation 3D Anterior Lumbar System

Applicant Corelink, LLC

K-Number K180556

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HKI 2018-07-27

RetiCapture

Applicant Ilooda Co,., Ltd.

K-Number K173474

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NKB 2018-07-27

Stowe Pedicle Screw System

Applicant Black Box Medical

K-Number K181554

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KTT 2018-07-27

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K180580

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IYN 2018-07-27

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K181485

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PPN 2018-07-26

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable

Applicant Shockwave Medical, Inc.

K-Number K180958

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