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

DZE 2025-10-10

HexaPLUS S OneDrill Implant System

Applicant Osseofuse International, Inc.

K-Number K243078

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FRO 2025-10-10

Tegaderm Post-Op Transparent Antimicrobial Dressing

Applicant Solventum US, LLC

K-Number K251866

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FIP 2025-10-09

DIASAFEplusUS (F00013010)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K251851

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IYN 2025-10-09

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K251651

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FER 2025-10-09

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)

Applicant Haemoband Surgical, Ltd.

K-Number K250645

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HRS 2025-10-09

Pediatric Plating Platform I Small-Mini

Applicant OrthoPediatrics Corp.

K-Number K252600

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OLT 2025-10-09

EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

Applicant Nihon Kohden Corporation

K-Number K251366

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MQB 2025-10-09

Lux HD 2530 detector (Lux HD 2530)

Applicant Iray Imaging Technology (Haining) Limited

K-Number K252911

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NFT 2025-10-09

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

Applicant Advin Biotech, Inc.

K-Number K252867

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OUR 2025-10-09

iFuse Bedrock Granite Implant System

Applicant SI-BONE, Inc.

K-Number K253094

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NFO 2025-10-09

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.

K-Number K252553

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NXC 2025-10-09

Invisalign Specifix Attachment System

Applicant Align Technology, Inc.

K-Number K252870

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