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

LHN 2024-01-12

PROBEAT-FR

Applicant Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

K-Number K232032

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GAW 2024-01-12

Cypris eXact Suturing System

Applicant Cypris Medical

K-Number K233355

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EOQ 2024-01-12

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

Applicant Pentax of America, Inc.

K-Number K231970

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ITI 2024-01-12

Velox Power Chair

Applicant Velox Manufacturing, Inc.

K-Number K231315

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MAX 2024-01-12

Meridian Interbody System; WaveForm A Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K233694

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MSH 2024-01-12

Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K233022

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FMF 2024-01-12

SMB Luer lock disposable syringe

Applicant Smb Corporation of India

K-Number K231558

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QNP 2024-01-12

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K233964

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GCJ 2024-01-12

MD Mattress Suture Placement Device

Applicant Lsi Solutions, Inc.

K-Number K222783

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ODP 2024-01-12

BEE Cervical Cage

Applicant NGMedical GmbH

K-Number K231371

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QOG 2024-01-12

SoloSmart Injection Pen Adapter (SoloSmart®)

Applicant Biocorp Production

K-Number K231820

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QZS 2024-01-12

DermaSensor

Applicant Dermasensor, Inc.

K-Number DEN230008

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