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

OLO 2025-04-25

Mako Total Knee Application (3.0); Hybrid Tip Pointer

Applicant Mako Surgical Corp.

K-Number K250608

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LXB 2025-04-25

contact forte Alpha

Applicant Bhm-Tech Produktionsgesellschaft Mbh

K-Number K243041

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GEX 2025-04-24

CO2 Laser System (CO2 Laser SST-L23)

Applicant Zhuozhou Summer Star Technologies Co., Ltd.

K-Number K250183

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MYN 2025-04-24

Lung AI (LAI001)

Applicant Exo, Inc.

K-Number K243239

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KNW 2025-04-24

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

Applicant SurGenTec, LLC

K-Number K243945

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DYB 2025-04-24

PeriCross Epicardial Access Kit

Applicant Circa Scientific, Inc.

K-Number K243954

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DXN 2025-04-24

Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K250116

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FMF 2025-04-24

GO-PEN®

Applicant Go-Pen Aps

K-Number K250262

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GEX 2025-04-24

Diode laser system (Night Universe; Predator)

Applicant Ivylaser (Beijing) Technology Co.,Ltd

K-Number K250206

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CCL 2025-04-24

Smart Check O2 (MA0236)

Applicant Life Spark Medical, LLC

K-Number K250002

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QZC 2025-04-24

Sonu

Applicant Sound Health Systems, Inc.

K-Number K242214

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NAY 2025-04-24

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K243714

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