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

FRG 2019-06-11

JAMBRO Single Core A Sterilization wrap

Applicant Jiangsu Zhande Medical Supplies Co., Ltd.

K-Number K182656

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MAI 2019-06-11

Arthrex SwiveLock Suture Anchor

Applicant Arthrex, Inc.

K-Number K191226

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NKB 2019-06-11

NOVA Minimally Invasive System

Applicant Baui Biotech Co., Ltd.

K-Number K182416

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HSB 2019-06-11

T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System

Applicant Stryker Trauma GmbH

K-Number K191271

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OLO 2019-06-11

Spine & Trauma Navigation

Applicant Brainlab AG

K-Number K191285

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MVL 2019-06-10

Vista FS, Vista FS Liquid

Applicant Inter-Med/Vista Dental Products

K-Number K190220

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IYN 2019-06-10

7410 Ultrasound System (MyLabSigma)

Applicant Esaote, S.p.A.

K-Number K191072

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HRS 2019-06-10

Arzzt Distal Radius and Ulna System

Applicant Truemed Group, LLC

K-Number K182650

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MQV 2019-06-10

AccuFill Bone Substitute Material

Applicant Zimmer Knee Creations

K-Number K190814

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JAA 2019-06-10

Insight Essentials DRF Digital Imaging System

Applicant Imaging Engineering, LLC

K-Number K191310

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HWC 2019-06-10

Mini Cannulated Headed and Headless Screw Set

Applicant Stryker GmbH

K-Number K183104

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OLO 2019-06-10

SPINEART Navigation Instrument System

Applicant Spineart SA

K-Number K183630

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