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

DJG 2020-09-17

LZI Oxycodone III Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K202007

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FXX 2020-09-17

Single-Use Surgical Mask With Ear Loop

Applicant Qiqihar Hengxin Medical Supplies, Ltd.

K-Number K201691

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OEG 2020-09-17

EUROIMMUN Anti-BP230-CF ELISA (IgG)

Applicant Euroimmun Us, Inc.

K-Number K193115

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OWB 2020-09-16

Ziehm Vision RFD 3D

Applicant Ziehm Imaging GmbH

K-Number K202360

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PLP 2020-09-16

Tulsa-Pro System

Applicant Profound Medical, Inc.

K-Number K202286

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OLO 2020-09-16

Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set

Applicant Medos International SARL

K-Number K201661

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HSB 2020-09-16

Precice® Ankle Salvage System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K200430

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DQK 2020-09-16

VX1

Applicant Volta Medical

K-Number K201298

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KGO 2020-09-16

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs

Applicant Pt. Medisafe Technologies

K-Number K201774

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LLZ 2020-09-16

AVA (Augmented Vascular Analysis)

Applicant See-Mode Technologies Pte, Ltd.

K-Number K201369

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OAS 2020-09-16

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

Applicant Genoray Co., Ltd.

K-Number K200469

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KPR 2020-09-16

EOSedge

Applicant Eos Imaging

K-Number K202394

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