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

FMI 2025-05-29

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

Applicant Terumo Europe N.V.

K-Number K243309

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IYN 2025-05-29

Voluson Performance 16; Voluson Performance 18

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K250543

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SEU 2025-05-29

Spur Peripheral Retrievable Stent System

Applicant Reflow Medical, Inc.

K-Number DEN240048

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NUH 2025-05-29

TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

Applicant Shenzhen Astec Technology Co., Ltd.

K-Number K243856

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HRS 2025-05-29

SIGNEX

Applicant Osteonic Co., Ltd.

K-Number K243469

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LJS 2025-05-29

PM2+ System and SmartPICC Stylet

Applicant Piccolo Medical, Inc.

K-Number K243484

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PEM 2025-05-29

Dental Barrier and Sleeves

Applicant Yueying Medical Instruments (Langfang) Co., Ltd.

K-Number K250606

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EIH 2025-05-29

CERABIEN MiLai

Applicant Kuraray Noritake Dental, Inc.

K-Number K250673

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EOQ 2025-05-29

Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K243497

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ONO 2025-05-29

Visualase V2 MRI-guided Laser Ablation System (9736422)

Applicant Medtronic Navigation

K-Number K250307

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OLO 2025-05-29

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

Applicant Remex Medical Corp.

K-Number K251315

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FGB 2025-05-28

Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)

Applicant Opcom Medical, Inc.

K-Number K242699

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