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

JXI 2025-07-22

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)

Applicant Alafair Biosciences

K-Number K251505

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GJS 2025-07-21

microINR System

Applicant Iline Microsystems, S.L.

K-Number K251564

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OBJ 2025-07-19

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

Applicant Jiangsu Tingsn Technology Co., Ltd.

K-Number K250913

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HRS 2025-07-18

Baby Gorilla®/Gorilla® Plating System

Applicant Paragon 28, Inc.

K-Number K250952

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HIH 2025-07-18

SPY Cystoscope/Hysteroscope

Applicant Stryker Endoscopy

K-Number K252012

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ODG 2025-07-18

InstaFAN

Applicant Onepass Medical , Ltd.

K-Number K251542

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OWW 2025-07-18

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)

Applicant Alafair Biosciences

K-Number K251655

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LHI 2025-07-18

HyHub and HyHub Duo Vial Access Devices

Applicant Takeda Pharmaceuticals

K-Number K243404

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NFO 2025-07-18

MF SC GEN2 Facial Toning System

Applicant Micro Current Technology, Inc.

K-Number K252218

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EBW 2025-07-18

ELEC ENGINE (Model: ISE-170L)

Applicant Micro-Nx Co., Ltd.

K-Number K231562

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IYN 2025-07-18

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K250999

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OBO 2025-07-18

Tomey Cornea/Anterior Segment OCT (CASIA2)

Applicant Tomey Corporation

K-Number K250553

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