Data / Medical devices / United States / Izi Medical Products LLC
Izi Medical Products LLC: FDA-registered device maker in Owings Mills, MD, United States, 22 510(k) clearances
Izi Medical Products LLC is registered with the FDA (registration 1123169) in Owings Mills, MD, United States. It lists 17 device types. The FDA files 22 510(k) clearances under its listings, the newest dated August 12, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1123169
- FEI number
- 1000123143
- Address
- 5 Easter Ct Ste J, Owings Mills, MD, United States, 21117
- Owner or operator
- IZI MEDICAL PRODUCTS LLC (9005298)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 19, 1993
- Registered through
- 2027
- Brand names listed
- BL Navigated Biopsy Needle, Blazer, Bone Biopsy Needles, Bone Cement Injector Set, Breast Lesion Localization Needle, Cement Mixer, Cold Care Pack, CushionCast Moldable Cushion and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2020 | K200763 | Osteo-site Vertebral Balloon | HRX | Substantially Equivalent | Izi Medical | accessdata.fda.gov |
| August 7, 2019 | K191012 | Navigated Pedicle Access Kit | OLO | Substantially Equivalent | Izi Medical Products, LLC | accessdata.fda.gov |
| April 28, 2017 | K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) | IYE | Substantially Equivalent | Radiomed Corporation | accessdata.fda.gov |
| February 28, 2017 | K170008 | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set | KNW | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 15, 2016 | K162265 | CushionCast Moldable Cushions | IYE | Substantially Equivalent | Izi Medical Products, LLC | accessdata.fda.gov |
| April 13, 2015 | K143241 | MDT Navigable Brain Biopsy Cannula | HAW | Substantially Equivalent | Izi Medical Products, LLC | accessdata.fda.gov |
| March 20, 2015 | K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System | HAW | Substantially Equivalent | Izi Medical Products, LLC | accessdata.fda.gov |
| December 5, 2014 | K140705 | NAVIGABLE BRAIN BIOPSY CANNULA SET | HAW | Substantially Equivalent | Izi Medical Products | accessdata.fda.gov |
| August 14, 2014 | K141141 | KIVA VCF TREATMENT SYSTEM | NDN | Substantially Equivalent | Benvenue Medical, Inc. | accessdata.fda.gov |
| April 19, 2012 | K120859 | PRE-LOADED GOLD VISICOIL CK MARKER | KXK | Substantially Equivalent | Radiomed Corporation | accessdata.fda.gov |
| February 25, 2011 | K103449 | BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS | KXK | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| January 3, 2011 | K103433 | F20 | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| August 28, 2008 | K080873 | OPACITY + BONE CEMENT | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| July 10, 2007 | K070293 | BENVENUE VCF OSTEO COIL SYSTEM | OCJ | Substantially Equivalent | Benvenue Medical, Inc. | accessdata.fda.gov |
| March 7, 2007 | K070305 | PRE-LOADED VISICOIL | IYE | Substantially Equivalent | Radiomed Corporation | accessdata.fda.gov |
| March 17, 2006 | K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | NDN | Substantially Equivalent | Teknimed, S.A. | accessdata.fda.gov |
| November 8, 2005 | K042691 | VERTEFIX VERTEBROPLASTY PROCEDURE SET | NDN | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| August 13, 2002 | K022074 | SPHERZ | HAW | Substantially Equivalent | I.Z.I. Corp. | accessdata.fda.gov |
| March 4, 2002 | K014022 | MRI LINE MARKER | IYE | Substantially Equivalent | I.Z.I. Corp. | accessdata.fda.gov |
| September 21, 1999 | K991319 | RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS | IYE | Substantially Equivalent | Orfit Industries | accessdata.fda.gov |
| November 3, 1997 | K973565 | QUICK-CARE BIOPSY NEEDLE | KNW | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| May 5, 1997 | K964972 | SHADOWFORM | KPQ | Substantially Equivalent | I.Z.I. Medical Products Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Cement, Bone, Vertebroplasty
- All makers of Mixer, Cement, For Clinical Use
- All makers of Pack, Hot Or Cold, Reusable
- All makers of System, Simulation, Radiation Therapy
- All makers of Instrument, Biopsy
Updated August 12, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.