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

QEW 2021-02-26

Indigo Aspiration System - Lightning Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K210323

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FAD 2021-02-25

Vortek Single Loop Ureteral Stent

Applicant Coloplast Corp.

K-Number K201436

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FXX 2021-02-25

Surgical Masks

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K-Number K203524

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ONB 2021-02-25

TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set

Applicant Simplivia Healthcare , Ltd.

K-Number K201142

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LRK 2021-02-25

Classic

Applicant Orthoapnea S.L.

K-Number K203477

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FLL 2021-02-25

Infrared Forehead Thermometer

Applicant Conmo Electronic Company Limited

K-Number K202420

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PAY 2021-02-25

STOP U Model UXV Device

Applicant Pollogen, Ltd.

K-Number K203665

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LLZ 2021-02-25

NinesMeasure

Applicant Nines, Inc.

K-Number K202990

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MUA 2021-02-25

EchoS Family

Applicant Echolight S.P.A

K-Number K202514

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NQQ 2021-02-25

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Applicant Perimeter Medical Imaging Ai, Inc.

K-Number K203578

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GEI 2021-02-25

Tixel System

Applicant Novoxel , Ltd.

K-Number K202988

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IYN 2021-02-25

SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K201969

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