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

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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QDS 2024-11-06

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

Applicant Biofire Diagnostics, LLC (Biomerieux)

K-Number K243222

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GCJ 2024-11-06

MultiCut Solo

Applicant Asclepion Laser Technologies GmbH

K-Number K240831

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OHT 2024-11-06

Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K242039

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MBH 2024-11-06

Agility Symmetric Total Knee System

Applicant Medisurge, LLC

K-Number K242412

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MQV 2024-11-06

Citrepore

Applicant Acuitive Technologies, Inc.

K-Number K240450

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DZE 2024-11-06

Accelx Implant System

Applicant Biotech Dental, LLC

K-Number K242261

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