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

NRY 2020-02-27

Penumbra System Penumbra JET 7X

Applicant Penumbra, Inc.

K-Number K191946

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QKE 2020-02-27

Proov Test

Applicant Mfb Fertility, Inc.

K-Number K191462

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MWI 2020-02-27

Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories

Applicant Masimo Corporation

K-Number K193242

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ODA 2020-02-27

INTELLIO Tablet Application

Applicant Smith & Nephew

K-Number K192876

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QJP 2020-02-27

CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm

Applicant Medos International SARL

K-Number K192804

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NHA 2020-02-26

Luna Dental Implant System- Healing Abutment

Applicant Shinhung Mst Co., Ltd.

K-Number K200189

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DZJ 2020-02-26

VSP System

Applicant 3D Systems

K-Number K192192

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JDR 2020-02-26

DePuy Synthes Hammertoe Continuous Compression Implant

Applicant Synthes (USA) Products, LLC

K-Number K191463

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MQP 2020-02-26

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System

Applicant Nu Vasive, Incorporated

K-Number K193506

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DJG 2020-02-26

ARK Fentanyl II Assay

Applicant Ark Diagnostics, Inc.

K-Number K200197

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PMU 2020-02-25

PneumoLiner

Applicant Advanced Surgical Concepts

K-Number K192898

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PMT 2020-02-25

VITROS BRAHMS PCT Reagent Pack and Calibrators

Applicant Ortho Clinical Diagnostics

K-Number K200236

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