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

QIH 2022-08-03

Customize

Applicant 3D-Side S.A.

K-Number K221432

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DHB 2022-08-03

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed

Applicant Phadia AB

K-Number K212181

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EKZ 2022-08-03

Root ZX3

Applicant J. Morita USA, Inc.

K-Number K213477

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QDQ 2022-08-03

Transpara 1.7.2

Applicant Screenpoint Medical B.V.

K-Number K221347

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HWC 2022-08-03

Cannulated Screws

Applicant Maxxion Medical, LLC

K-Number K213614

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DSH 2022-08-02

QOCA Portable ECG Monitoring Device

Applicant Quanta Computer, Inc.

K-Number K210179

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EIH 2022-08-02

BruxZir NOW

Applicant Prismatik Dentalcraft, Inc.

K-Number K220816

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KYF 2022-08-02

iStent infinite Trabecular Micro-Bypass System, Model iS3

Applicant Glaukos Corporation

K-Number K220032

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OHT 2022-08-01

IPL hair removal

Applicant Shenzhen Lizbella Technology Co.,Ltd

K-Number K221451

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FLE 2022-08-01

Consolidated HC Steam Sterilizer

Applicant Consolidated Machine Corp.

K-Number K220736

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LZA 2022-08-01

Disposable Medical Nitrile Examination Gloves

Applicant Fujian Jixiang Medical Technology Co.,Ltd

K-Number K220237

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MQB 2022-08-01

X-ray Flat Panel Detectors (CareView 1800 RF)

Applicant Careray Digital Medical Technology Co., Ltd.

K-Number K221549

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