FDA Registration
Active
🇺🇸 United States
IZI MEDICAL PRODUCTS LLC
Reg #: 1123169
·
FEI: 1000123143
·
Expires 2026
Products
16
Proprietary Names
30
Establishment Types
4
Classifications
16
Registration Details
- Registration Name
- IZI MEDICAL PRODUCTS LLC
- Registration Number
- 1123169
- FEI Number
- 1000123143
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5 Easter Ct Ste J
- City
- Owings Mills
- State
- MD
- ZIP
- 21117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103449
Owner / Operator
- Firm Name
- IZI MEDICAL PRODUCTS LLC
- Operator Number
- 9005298
- Address
- 5 Easter Court, Suite J
- City
- Owings Mills
- State
- MD
- Postal Code
- 21117
- Country
- US
- Correspondent
- Qiang - Cao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2017-03-01 |
| Source, Brachytherapy, Radionuclide | KXK | Class 2 | Radiology | No | 2017-03-01 |
| Needle, Tumor Localization | MIJ | Class 1 | General, Plastic Surgery | No | 2020-01-15 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2018-02-15 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2019-10-30 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2018-07-27 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-08-21 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2007-11-09 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2018-02-12 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-09-22 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2012-09-10 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2021-02-22 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2021-03-12 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2018-07-27 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 1993-11-19 |
| System, Simulation, Radiation Therapy | KPQ | Class 2 | Radiology | No | 2007-11-09 |
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
ShadowForm Markers
Quick-Core Biopsy Needle
IZI Thermoplastic Mask
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility