Izi Medical Products LLC
Owings Mills, MD, US
IZI MEDICAL PRODUCTS LLC appears in FDA device records in Owings Mills, MD. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Izi Medical Products LLC between 1996 and 2019. The busiest year on record is 1999, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 2 |
| 2010 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191012 | Navigated Pedicle Access Kit | OLO | Substantially Equivalent | |
| K162265 | CushionCast Moldable Cushions | IYE | Substantially Equivalent | |
| K143241 | MDT Navigable Brain Biopsy Cannula | HAW | Substantially Equivalent | |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System | HAW | Substantially Equivalent | |
| K140705 | NAVIGABLE BRAIN BIOPSY CANNULA SET | HAW | Substantially Equivalent | |
| K101373 | EMBRACE | IZH | Substantially Equivalent | |
| K990298 | TOPOGRAPHIC IMAGING MARKER | KPR | Substantially Equivalent | |
| K990242 | TOPOGRAPHIC IMAGING MARKER | KPR | Substantially Equivalent | |
| K964972 | SHADOWFORM | KPQ | Substantially Equivalent | |
| K962606 | TOPOGRAPHIC IMAGING MARKER | JAA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1123169 | 1000123143 | IZI MEDICAL PRODUCTS LLC | 5 Easter Ct Ste J, Owings Mills, MD 21117 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- HRXArthroscope
- LODBone Cement
- NDNCement, Bone, Vertebroplasty
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- KNWInstrument, Biopsy
- FZZMarker, Skin
- JDZMixer, Cement, For Clinical Use
- MIJNeedle, Tumor Localization
- HAWNeurological Stereotaxic Instrument
- OLOOrthopedic Stereotaxic Instrument
- IMEPack, Hot Or Cold, Reusable
- KXKSource, Brachytherapy, Radionuclide
- OCJSpinal Channeling Instrument, Vertebroplasty
- KPQSystem, Simulation, Radiation Therapy
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain