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

GEX 2025-10-08

The Botticelli (Model: Athena)

Applicant Bellamia Technologies, Inc.

K-Number K251699

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FOZ 2025-10-08

BD Saf-T-Intima™ Subcutaneous Catheter System

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K251422

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HDB 2025-10-08

Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

Applicant Clinical Innovations, LLC

K-Number K250298

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QIH 2025-10-07

AIAS Cephalon

Applicant Metamorphosis GmbH

K-Number K252214

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IYE 2025-10-07

TrueBeam, TrueBeam STX, Edge and VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K252948

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OUR 2025-10-07

Eminent Spine Posterior SI System

Applicant Eminent Spine

K-Number K250894

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LPL 2025-10-07

Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Applicant St. shine Optical Co., Ltd.

K-Number K250364

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FED 2025-10-07

Prodeon Urethral Sheath System

Applicant Prodeon Medical, Inc.

K-Number K252572

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GEI 2025-10-07

Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)

Applicant Olympus Medical Systems Corporation

K-Number K252150

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IMG 2025-10-07

Ultrasound Therapy Workstation (XMS-UET2)

Applicant Xemis Medical Technology (Shenzhen) Co., Ltd.

K-Number K244041

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NQQ 2025-10-07

deepLive (OSP12 + DMS)

Applicant Damae Medical

K-Number K252851

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KGE 2025-10-07

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

Applicant Olympus Medical Systems Corporation

K-Number K250187

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