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

GCJ 2021-09-17

RedEx

Applicant Advanced Surgical Concepts, Ltd.

K-Number K211234

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MQB 2021-09-17

Intelligent NR

Applicant Canon, Inc.

K-Number K212269

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OAT 2021-09-17

Syntec Orthodontic Mini Screw Extended System

Applicant Syntec Scientific Corporation

K-Number K202790

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HEB 2021-09-17

Tempo Natural Tampon

Applicant Dong-A Pharmaceutical Co., Ltd.

K-Number K212272

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CAF 2021-09-17

BreatheSuite MDI V1

Applicant Breathesuite, Inc.

K-Number K203155

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CCK 2021-09-17

Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

Applicant Covidien

K-Number K203762

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LYZ 2021-09-17

Vinyl Glove

Applicant Jiangsu Dihong Industry and Trade Co., Ltd.

K-Number K211904

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FXX 2021-09-17

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

Applicant Ningbo Ouhan Medical Device Co., Ltd.

K-Number K203418

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KPI 2021-09-17

Incontinence Probe

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K210441

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KNW 2021-09-17

Uramix CuraWay Biopsy Needle

Applicant Uramix, Inc.

K-Number K203141

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PSY 2021-09-17

Philips IntelliSite Pathology Solution

Applicant Philips Medical Systems Nederland B.V.

K-Number K203845

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FXX 2021-09-16

Disposable Medical Mask

Applicant Yangzhou Runyi Arts & Crafts Co., Ltd.

K-Number K203112

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