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

HSB 2024-02-12

I.T.S. INS Proximal Femur Nail

Applicant I.T.S. GmbH

K-Number K233134

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IYO 2024-02-12

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

Applicant Eieling Technology Limited

K-Number K233401

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NFO 2024-02-12

Facial Toning device (UIC-189); Facial Toning device (UIC-589)

Applicant Body Trim Industrial Co., Ltd.

K-Number K233667

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LLZ 2024-02-12

Mimics Cardiac Planner

Applicant Materialise NV

K-Number K233217

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HIH 2024-02-12

Endoscopic Video Image Processor, Single-Use Video Hysteroscope

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K232003

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NUH 2024-02-12

EMS/TENS Massager Device

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K233040

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MNR 2024-02-09

Aurora

Applicant Ensodata

K-Number K231355

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FLL 2024-02-09

Infrared Thermometer: Model YJ600

Applicant Zhuhai Yueja Medical Device Technology Co., Ltd.

K-Number K232473

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GEI 2024-02-09

AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G

Applicant H.S Hospital Service S.P.A

K-Number K232072

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HKY 2024-02-09

CATS-L Tonometer™ Prism

Applicant Cats Tonometer, LLC

K-Number K234037

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DRT 2024-02-09

Neteera 130H-Plus Vital Sign Monitoring Sensor

Applicant Neteera Technologies , Ltd.

K-Number K231733

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OBP 2024-02-09

ZapStim Controller Application (Z1023)

Applicant Revital Lab, Inc.

K-Number K233631

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