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

BSP 2020-05-27

Stimuplex Onvision System

Applicant Philips Medical Systems Nederland B.V.

K-Number K192914

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GXZ 2020-05-27

Guardian Needle Electrode

Applicant Rhythmlink International, LLC

K-Number K200984

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GEX 2020-05-27

Medical Diode Laser Hair Removal System

Applicant Weifang Mingliang Electronics Co., Ltd.

K-Number K200525

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OLR 2020-05-27

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse

Applicant Synedgen, Inc.

K-Number K193336

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HQC 2020-05-27

Phacoemulsification Needle (Tip) and Irrigation Sleeve

Applicant Raico, LLC

K-Number K192418

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OZR 2020-05-26

The iNAP One Sleep Therapy System

Applicant Somnice, Inc.

K-Number K193460

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EFB 2020-05-26

High-speed air turbine handpiece / Low-speed air turbine handpiece

Applicant Foshan Wenjian Medical Instrument Co., Ltd.

K-Number K181691

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KLE 2020-05-26

DiaPlus

Applicant DiaDent Group International

K-Number K192392

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IYN 2020-05-26

ACUSON Juniper Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K201130

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PHL 2020-05-26

ReWalk P6.0

Applicant Re Walk Robotics , Ltd.

K-Number K200032

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OKO 2020-05-26

NPseal

Applicant Guard Medical, Inc.

K-Number K200305

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GEX 2020-05-26

GentleMax Pro Plus

Applicant Candela Corporation

K-Number K201111

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