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

EBI 2018-10-12

Juell 3D Volo Base

Applicant Park Dental Research Corporation

K-Number K181220

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NRY 2018-10-12

Penumbra System (Modified 110 Aspiration Tubing)

Applicant Penumbra, Inc.

K-Number K182522

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LNH 2018-10-12

MAGNETOM Sola

Applicant Siemens Medical Solutions USA, Inc.

K-Number K182129

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JWH 2018-10-12

b-ONE Total Knee System

Applicant B-One Ortho, Corp.

K-Number K180446

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DYB 2018-10-12

Endophys Pressure Sensing Sheath Kit

Applicant Endophys Holdings, LLC

K-Number K180620

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JOW 2018-10-12

Radial Medical Compression System

Applicant Radial Medical, Inc.

K-Number K181651

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JWH 2018-10-12

BKS Revision Sleeves System

Applicant Ortho Development Corporation

K-Number K181569

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GEI 2018-10-12

Percuvance Percutaneous Surgical System

Applicant Teleflexmedical, Inc.

K-Number K181852

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JDQ 2018-10-12

Thorecon Rigid Fixation System

Applicant A & E Medical Corporation

K-Number K181607

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NQW 2018-10-12

Life Spine Laminoplasty System

Applicant Life Spine, Inc.

K-Number K181717

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BSK 2018-10-12

AG 100s

Applicant Hospitech Respiration , Ltd.

K-Number K180991

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DCN 2018-10-12

Optilite High Sensitivity C-Reactive Protein Kit

Applicant The Binding Site Group , Ltd.

K-Number K180099

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