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

LLZ 2021-09-10

EFAI PACS Picture Archiving and Communication System

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K211257

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IYN 2021-09-10

LOGIQ E10

Applicant GE Healthcare

K-Number K211488

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FLL 2021-09-09

Electronic Thermometer (XHF2001, XHF2002)

Applicant Putian Hanjiang Huafeng Plastic Co., Ltd.

K-Number K211352

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IYN 2021-09-09

HERA W9, HERA W10 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K211824

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FMF 2021-09-09

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K211242

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OUR 2021-09-09

Curiteva Sacroiliac Joint Fusion System

Applicant Curiteva, Inc.

K-Number K210402

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KJJ 2021-09-09

EPIEN Dental Cleanser

Applicant Epien Medical, Inc.

K-Number K201785

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DWM 2021-09-09

Rocket Platinum Cured Cathter

Applicant Rocket Medical Plc

K-Number K210509

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MPN 2021-09-09

Exofin Precision Pen

Applicant Chemence Medical, Inc.

K-Number K212246

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OZN 2021-09-09

cobas Cdiff nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K210385

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MQB 2021-09-09

DIGITAL RADIOGRAPHY CXDI-Pro, D1

Applicant Canon, Inc.

K-Number K212553

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GXN 2021-09-08

Longeviti ClearFit OTS Cranial Implants

Applicant Longeviti Neuro Solutions, LLC

K-Number K212058

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