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

KNW 2017-03-20

Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm

Applicant Avitus Orthopaedics, Inc.

K-Number K170539

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HSB 2017-03-20

Flex-Thread Clavicle Pin System

Applicant Intrafuse, LLC

K-Number K163488

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ITI 2017-03-20

Luggie Chair

Applicant Freerider Corporation

K-Number K160139

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MRR 2017-03-20

Direct LDL Cholesterol (LDL)

Applicant Randox Laboratories Limited

K-Number K161691

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MUH 2017-03-20

Bel-Cypher Pro

Applicant Takara Belmont Corporation

K-Number K163175

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GZT 2017-03-20

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Applicant Tedan Surgical Innovations, LLC

K-Number K161318

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FMF 2017-03-20

Sterile Single-use Syringe with Needle

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K-Number K163161

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BSO 2017-03-17

UltraCath Continuous Nerve block Catheter

Applicant Teleflexmedical, Inc.

K-Number K162522

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GEX 2017-03-17

Sparkling

Applicant Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

K-Number K163655

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MAI 2017-03-17

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver

Applicant Conmed Corporation

K-Number K170501

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DZE 2017-03-17

Noris Medical MBI-2mm Dental Implant System

Applicant Noris Medical , Ltd.

K-Number K162308

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CCK 2017-03-17

OC-FLEX Flexible IntraOral Cannula

Applicant Venture Therapeutics, Inc.

K-Number K161250

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