IZI MEDICAL PRODUCTS LLC

FDA Device Registration & Listing · Owings Mills, MD, US · Registration 1123169

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1123169
FEI Number
1000123143
Entity Name
IZI MEDICAL PRODUCTS LLC
City/State/Country
Owings Mills, MD, US
Establishment Address
5 Easter Ct Ste J, Owings Mills, MD 21117, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IZI MEDICAL PRODUCTS LLC (Owner Number: 9005298)
Owner / Operator Contact Address
5 Easter Court, Suite J, Owings Mills, MD 21117, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IZI Gold Fiducial Markers Breast Lesion Localization Needle Multi-Modality Markers Thermoplastic Mask Vertefix Bone Cement VBC-200 Navigated Pedicle Access Kit KIVA VCF Treatment System Osteo-Site Vertebral Balloon Spherz Bone Biopsy Needles Disposable Passive Accessory AccuCushions™ KLARITY SHELL SYSTEM* for Klarity AccuCushions™ Navigated Brain Biopsy Cannula - Compatible Medtronic VBC-300 VBC BL Navigated Biopsy Needle Visicoil Cold Care Pack CushionCast Moldable Cushion Bone Cement Injector Set Cement Mixer Blazer Indicator Mammography Markers Indicator Radiolucent Markers Indicator Radiopaque Markers

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-03-01
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2017-03-01
MIJ Needle, Tumor Localization General, Plastic Surgery Class 1 878.4800 2020-01-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-11-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-09-22
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2012-09-10
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-02-15
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-02-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-10-30
LOD Bone Cement Orthopedic Class 2 888.3027 2018-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-07-27
HRX Arthroscope Orthopedic Class 2 888.1100 2020-08-21
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2020-08-21
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2007-11-09
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-02-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-03-31
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-01-05
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-08-06
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-02-15
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-02-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-01-05
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-09-22
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-09-22
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2012-09-10
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-03-01
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2021-02-22
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2021-03-12
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2018-07-27
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 1993-11-19

Official Correspondent

Qiang Cao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IZI MEDICAL PRODUCTS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1123169. Last updated year: 2026. Please use registration number 1123169 when referencing this establishment in official correspondence.
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