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

QIR 2020-04-29

CARPEDIEM System

Applicant Bellco Srl (Now Part of Medtronic, Inc)

K-Number DEN180055

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NKG 2020-04-28

Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

Applicant Corelink, LLC

K-Number K200863

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FLL 2020-04-28

Vicks VNT200 No Touch Forehead Thermometer

Applicant Kaz USA, Inc., A Helen of Troy Company

K-Number K193213

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NKG 2020-04-28

Solstice CCI

Applicant Life Spine, Inc.

K-Number K200896

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HSB 2020-04-28

Affixus(R) Natural Nail(R) System Humeral Nail

Applicant Zimmer GmbH

K-Number K200814

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OVD 2020-04-28

Hive Stand-alone Anterior Lumbar Interbody System

Applicant Hd Lifesciences, LLC

K-Number K200541

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FBK 2020-04-28

Single Use Injector

Applicant Olympus Medical Systems Corp.

K-Number K192498

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DZE 2020-04-28

Magicore II System

Applicant Innobiosurg Co., Ltd.

K-Number K192197

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LON 2020-04-28

VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

Applicant bioMerieux, Inc.

K-Number K200590

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DZE 2020-04-28

Implantswiss Dental Implant System and Implantswiss Dental Abutment System

Applicant Novodent SA

K-Number K200867

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DZE 2020-04-28

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K193592

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QEW 2020-04-27

WOLF Thrombectomy V System

Applicant Devoro Medical, Inc.

K-Number K200101

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