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

OLO 2020-10-27

Mazor X

Applicant Mazor Robotics , Ltd.

K-Number K203005

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NKB 2020-10-26

ACURA Stabilization System

Applicant Indius Medical Technologies Pvt. , Ltd.

K-Number K200937

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LZA 2020-10-26

Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)

Applicant Medline Industries, Inc.

K-Number K200150

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DQY 2020-10-26

coraForce and coraFlex Support Catheters

Applicant Reflow Medical, Inc.

K-Number K201811

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NKB 2020-10-26

Cannulated Power Driver Attachment

Applicant K2m, Inc.

K-Number K202528

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LYZ 2020-10-26

Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K202179

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FDF 2020-10-26

G-EYE System

Applicant Smart Medical Systems , Ltd.

K-Number K202469

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OVE 2020-10-26

DOLOMITE Anterior Cervical Stabilization System

Applicant Astura Medical, LLC

K-Number K202065

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MQB 2020-10-26

1212FCA

Applicant Rayence Co., Ltd.

K-Number K202722

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HRS 2020-10-26

AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System

Applicant Advanced Orthopaedic Solutions, Inc.

K-Number K202489

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NUH 2020-10-24

Li-Battery powered OTC TENS/EMS Combination Stimulator

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K201335

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MUE 2020-10-23

Planmed Clarity 2D and Clarity S

Applicant Planmed OY

K-Number K192317

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