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 2023-10-16

Ikshana

Applicant Immersivetouch

K-Number K230249

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GCJ 2023-10-16

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

Applicant Hunan Endoso Life Technology Co., Ltd.

K-Number K231725

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EGJ 2023-10-16

Iontophoresis Electrodes

Applicant Top-Rank Health Care Co., Ltd.

K-Number K232020

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FLL 2023-10-14

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K232128

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LLZ 2023-10-13

Veuron-Brain-pAb3

Applicant Heuron Co., Ltd.

K-Number K231642

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ODP 2023-10-13

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

Applicant Gbs Commonwealth Co., Ltd.

K-Number K232822

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FRO 2023-10-13

APIS (R), VERIS (TM)

Applicant Sweetbio, Inc.

K-Number K222143

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NPM 2023-10-13

S1

Applicant Medpark Co., Ltd.

K-Number K231672

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DQY 2023-10-13

Paragon 8F Balloon Guide Catheter

Applicant Wallaby Medical

K-Number K232437

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BTT 2023-10-13

BONHAWA Respiratory Humidifier

Applicant Telesair, Inc.

K-Number K223863

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GEI 2023-10-13

The Evolve System with the Transform Applicator

Applicant InMode , Ltd.

K-Number K231495

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LCX 2023-10-13

Macro & Micro-Test HCG Pregnancy Test Midstream

Applicant Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

K-Number K230741

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