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

DXN 2023-10-11

Arm Blood Pressure Monitor

Applicant Alicn Medical Shenzhen, Inc.

K-Number K231050

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NKB 2023-10-11

Vital™ Spinal Fixation System

Applicant Zimvie Spine (Zimmer Biomet Spine, Inc.)

K-Number K230116

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DQX 2023-10-11

VASSALLO GT 018 G12; VASSALLO GT 018 G30

Applicant Filmec Co. , Ltd.

K-Number K232578

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OWB 2023-10-11

Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR

Applicant GE Medical Systems SCS

K-Number K232344

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DZE 2023-10-11

MegaGen Dental Implant Systems Portfolio - MR Conditional

Applicant Megagen Implant Co., Ltd.

K-Number K230618

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DQX 2023-10-11

VASSALLO GT Crossing14

Applicant Filmec Co. , Ltd.

K-Number K232574

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GEI 2023-10-11

Disposable electrosurgical pencil (MD1000)

Applicant Shenzhen Mecun Medical Supply Co., Ltd.

K-Number K232460

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NUC 2023-10-11

JO Coconut Hybrid Warming Personal Lubricant

Applicant CC Wellness, LLC

K-Number K232090

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OBO 2023-10-11

Anterion

Applicant Heidelberg Engineering GmbH

K-Number K230897

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LNH 2023-10-11

Synq Software Version 1.3

Applicant Synaptive Medical, Inc.

K-Number K232981

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LZO 2023-10-11

EMPHASYS Femoral Stems

Applicant Depuy Ireland UC

K-Number K233233

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GWL 2023-10-11

Vlab

Applicant Dormotech Medical, Ltd.

K-Number K230148

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