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 2024-11-07

LL Implant System

Applicant Ossvis Co., Ltd.

K-Number K242379

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OLO 2024-11-07

Mako Shoulder Application (1.0)

Applicant Mako Surgical Corp.

K-Number K242373

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CCK 2024-11-07

MicroTrend System

Applicant Exostat Medical, Inc.

K-Number K212425

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PBF 2024-11-07

Newclip Patient-matched instrumentation non sterile PSI

Applicant Newclip Technics

K-Number K240415

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QBS 2024-11-07

icobrain aria

Applicant Icometrix NV

K-Number K240712

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NEU 2024-11-07

Trilogy Tissue Marker

Applicant Inrad, Inc.

K-Number K240429

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PCH 2024-11-07

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Applicant Biofire Diagnostics, LLC

K-Number K242367

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QSM 2024-11-07

Remanufactured EndoWrist ProGrasp Forceps (420093)

Applicant Rebotix

K-Number K241872

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QAS 2024-11-07

NeuroICH

Applicant Neurocareai, Inc.

K-Number K241719

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ODP 2024-11-07

ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System

Applicant Zsfab

K-Number K242734

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MQP 2024-11-07

Vertiwedge® Intraosseous System

Applicant Foundation Surgical Group, Inc.

K-Number K241468

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MQB 2024-11-07

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)

Applicant Aspen Imaging Healthcare, Inc.

K-Number K241346

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