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

QFM 2022-12-05

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K222692

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LZA 2022-12-04

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl

Applicant Zibo Lanhua Medical Packaging Material Co., Ltd.

K-Number K222815

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NLF 2022-12-04

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

Applicant Stryker Sustainability Solutions

K-Number K222019

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LZA 2022-12-04

Disposable Nitrile Examination Gloves

Applicant Jiangxi Handspro Products Solutions Co., Ltd.

K-Number K223004

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LZA 2022-12-03

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Safeskin Retailing (Hk) Limited

K-Number K222715

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NGX 2022-12-03

truSculpt flex

Applicant Johari Digital Healthcare Limited

K-Number K212866

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LZA 2022-12-03

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Safeskin Retailing (Hk) Limited

K-Number K222720

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LZA 2022-12-03

White Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Safeskin Retailing (Hk) Limited

K-Number K222713

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JOJ 2022-12-02

Chemical Indicator for Steam

Applicant True Indicating, LLC

K-Number K220778

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EOX 2022-12-02

PENTAX Medical Video Esophagoscope EE17-J10

Applicant Pentax of America, Inc.

K-Number K223072

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KNW 2022-12-02

SUREcore Plus Biopsy Instrument

Applicant Uro-1, Inc.

K-Number K220611

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MWI 2022-12-02

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K221113

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