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

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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HKI 2020-04-27

Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

Applicant Optina Diagnostics

K-Number K200254

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DQA 2020-04-27

Leadtek Fingertip Pulse Oximeter

Applicant Leadtek Research, Inc.

K-Number K193350

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MUJ 2020-04-27

Panther Stereotactic

Applicant Prowess, Inc.

K-Number K193459

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DYH 2020-04-27

GlassLok Kits, GlassLok Powder, GlassLok Liquid

Applicant Reliance Orthodontic Products, Inc.

K-Number K193388

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