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

QEP 2019-08-08

binx health io CT/NG Assay

Applicant Binx Health, Inc.

K-Number K191352

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FFX 2019-08-08

Transit-Pellets

Applicant Medifactia AB

K-Number K181760

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NHN 2019-08-08

Erchonia EVRL

Applicant Erchonia Corporation

K-Number K191257

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LPN 2019-08-08

REFRESH RELIEVA For CONTACTS

Applicant Allergan, Inc.

K-Number K190674

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HRS 2019-08-08

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System

Applicant In2bones USA, LLC

K-Number K190385

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LDF 2019-08-08

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K-Number K190716

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PPN 2019-08-07

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)

Applicant Shockwave Medical, Inc.

K-Number K191840

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HAW 2019-08-07

7D Surgical System

Applicant 7D Surgical, Inc.

K-Number K183276

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MQV 2019-08-07

BonAlive Granules

Applicant Bonalive Biomaterials, Ltd.

K-Number K191274

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DYB 2019-08-07

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set

Applicant Boston Scientific Corporation

K-Number K191871

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OVE 2019-08-07

Elevation Spine Saber-C System

Applicant Elevation Spine

K-Number K190885

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KFM 2019-08-07

Revolution Centrifugal Blood Pump

Applicant Sorin Group Italia S.R.L.

K-Number K190650

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