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

LZO 2025-01-06

Conformity Stem Extension Line, #0

Applicant United Orthopedic Corporation

K-Number K243466

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KPR 2025-01-06

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

Applicant Shenzhen Sontu Medical Imaging Equipment Co., Ltd.

K-Number K242499

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KGN 2025-01-06

DermiSphere Dermal Template

Applicant Fesariustherapeutics, Inc.

K-Number K241904

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INI 2025-01-06

WHILL Model R

Applicant Whill, Inc.

K-Number K242760

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GEI 2025-01-03

DUET-V (Model: ESK-3261DV)

Applicant Eunsung Global Corp

K-Number K233118

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GWN 2025-01-03

Synapsys VHIT

Applicant Inventis S.R.L.

K-Number K242726

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QAS 2025-01-03

JLK-ICH

Applicant JLK, Inc.

K-Number K243363

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FDF 2025-01-03

PENTAX Medical Video Colonoscope (EC38-i20cWL)

Applicant Pentax of America, Inc.

K-Number K242110

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JAK 2025-01-03

syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K241757

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NHA 2025-01-03

NobelProcera Zirconia Implant Bridge

Applicant Nobel Biocare AB

K-Number K240346

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MMI 2025-01-03

i-STAT hs-TnI cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K240984

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MRN 2025-01-03

EVOLVE Nitric Oxide Delivery System

Applicant Mallinckrodt Manufacturing, LLC

K-Number K242578

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