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

PZR 2021-11-05

Drug Relief v1

Applicant Dyansys, Inc.

K-Number K211971

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LYY 2021-11-05

Best Glove-Latex Powder Free Examination Glove

Applicant Bestsafe Glove Co., Ltd.

K-Number K210253

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GZI 2021-11-05

MStim Drop Model: LGT-233

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K202110

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OWB 2021-11-05

VFSS Pro Mobile Digital Imaging System

Applicant Imagexray, LLC

K-Number K212523

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GCJ 2021-11-05

SoftFix Balloon Trocar

Applicant Unimax Medical Systems, Inc.

K-Number K211577

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LZA 2021-11-05

Nitrile Examination Gloves

Applicant Anhui Fine Glove Medical Technology Co., Ltd.

K-Number K212551

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NFO 2021-11-05

Microcurrent device (Model: HBR2-1)

Applicant Shenzhen DJ Medical Equipment Co., Ltd.

K-Number K211055

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OVE 2021-11-05

Cervical Stand-Alone System

Applicant Eminent Spine, LLC

K-Number K212853

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LLZ 2021-11-05

Visible Patient Suite

Applicant Visible Patient, Sas

K-Number K212896

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OOK 2021-11-05

CoolSculpting Elite System

Applicant Zeltiq Aesthetics, Inc.

K-Number K212707

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IYN 2021-11-05

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System

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

K-Number K212900

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LZA 2021-11-05

Disposable Nitrile Examination gloves

Applicant Fujian Yuanxin Safety Protection Technology Co., Ltd.

K-Number K212485

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