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

LLZ 2021-11-12

MiPACS HTML5 Web Viewer

Applicant Lead Technologies, Inc.

K-Number K212984

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MQC 2021-11-12

NightGuard Flex

Applicant Sprintray, Inc.

K-Number K212448

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JWY 2021-11-12

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

Applicant Biomerieux S.A.

K-Number K210757

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CFF 2021-11-12

HYDRASHIFT 2/4 isatuximab

Applicant Sebia

K-Number K203184

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LZA 2021-11-11

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

Applicant Crdlight Optoelectronic Technology Co., Ltd.

K-Number K212532

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DQK 2021-11-11

EnSite X EP System

Applicant ABBOTT MEDICAL

K-Number K213364

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LZA 2021-11-11

Nitrile Examination Glove (Powder free, Blue)

Applicant Jiangsu Jinlian Medical Technology Co., Ltd.

K-Number K212497

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DQD 2021-11-10

eKuore Pro 4T - REF EP0098

Applicant Chip Ideas Electronics S.L.

K-Number K212013

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GEX 2021-11-10

Diode laser therapy system

Applicant Beijing Unt Technology Co., Ltd.

K-Number K212978

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PMU 2021-11-10

More-Cell-System

Applicant Agency For Medical Innovations GmbH

K-Number K212659

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OTN 2021-11-10

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

Applicant Caldera Medical, Inc.

K-Number K211975

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LZA 2021-11-10

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Shandong Shangwei Medical Products Co., Ltd.

K-Number K210779

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