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

FMI 2025-07-24

TSK SELECT™ Needle

Applicant Tsk Laboratory, Japan

K-Number K250284

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OHT 2025-07-24

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K251984

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IRP 2025-07-23

Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)

Applicant Xiamen Taotao Technology Co., Ltd.

K-Number K242615

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DRF 2025-07-23

MAGiC Sweep™ EP Mapping Catheter

Applicant Stereotaxis, Inc.

K-Number K250590

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DZE 2025-07-23

SD TL Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K250280

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LLZ 2025-07-23

Neuro Insight V1.0

Applicant Olea Medical S.A.S.

K-Number K243681

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OLO 2025-07-23

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

Applicant Innovasis, Inc.

K-Number K251073

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ESW 2025-07-23

Resilience Fully Covered Esophageal Stent System

Applicant Merit Medical Systems, Inc.

K-Number K251265

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MQF 2025-07-23

Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)

Applicant Vitrolife Sweden AB

K-Number K243373

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DZE 2025-07-23

DESS® Dental Implants

Applicant Terrats Medical SL

K-Number K251280

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NAY 2025-07-23

Da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251213

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LLZ 2025-07-23

IMAGE ONE

Applicant Infomed Software, S.L.

K-Number K250716

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