Data / Medical devices / United States / Best Medical International, Inc.
Best Medical International, Inc.: FDA-registered device maker in Springfield, VA, United States, 18 510(k) clearances
Best Medical International, Inc. is registered with the FDA (registration 1120804) in Springfield, VA, United States. It lists 5 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1120804
- Address
- 7639 & 7643 Fullerton RD., Springfield, VA, United States, 22153
- Owner or operator
- BEST MEDICAL INTERNA (9001621)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 1, 1992
- Registered through
- 2026
- Brand names listed
- Adjustable, Afterloading Catheters, Anderson Markers, Au 198 Source, Best Brachytherapy Applicator, Best Cartridge & Gun, Best Localization Needle with I-125 seed, Best Medical International, Inc and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Shield, Eye, Radiological | IWS | 1 | Manufacturer | accessdata.fda.gov |
| Source, Brachytherapy, Radionuclide | KXK | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Source, Isotope, Sealed, Gold, Titanium, Platinum | IWI | 2 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| April 13, 2018 | K162499 | Best Instruminal Applicator | JAQ | Substantially Equivalent | Best Medical International, Inc. | accessdata.fda.gov |
| September 30, 2013 | K132097 | BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY | JAQ | Substantially Equivalent | Best Medical International, Inc. | accessdata.fda.gov |
| January 9, 2013 | K122704 | BEST LOCALIZATION NEEDLE WITH I-125 SEED | KXK | Substantially Equivalent | Best Medical Intl. | accessdata.fda.gov |
| August 4, 2006 | K061638 | BEST STRAND AND BEST SPACER | KXK | Substantially Equivalent | Best Medical International, Inc. | accessdata.fda.gov |
| December 9, 2004 | K043117 | BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER | KXK | Substantially Equivalent | Best Medical International, Inc. | accessdata.fda.gov |
| November 18, 2004 | K042786 | BEST MODEL # 81-01 SERIES IR-192 SOURCES | KXK | Substantially Equivalent | Best Medical International, Inc. | accessdata.fda.gov |
| November 3, 2004 | K042586 | BEST BREAST BRACHYTHERAPY APPLICATOR | JAQ | Substantially Equivalent | Best Medical International, Inc. | accessdata.fda.gov |
| December 30, 1994 | K940121 | IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS | IWJ | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| December 30, 1994 | K940119 | ROYAL MARSDEN GOLD GRAIN GUN | IWS | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| December 30, 1994 | K933410 | IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES | IWJ | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| July 27, 1993 | K932242 | RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 | KXK | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| June 4, 1993 | K930570 | RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES | KXK | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| June 4, 1993 | K924290 | BEST INDUSTRIES CARTRIDGE & GUN | IWJ | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| June 4, 1993 | K924261 | RADIOACTIVE CESIUM-131 SEEDS/SOURCES | KXK | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| August 9, 1991 | K912170 | RADIOACTIVE IODINE-125 SOURCES | IWI | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| June 10, 1991 | K910710 | RADIOACTIVE SEEDS | KXK | Substantially Equivalent | Best Assoc. Corp. | accessdata.fda.gov |
| April 18, 1991 | K910862 | VARIOUS TEMPLATE APPLICATORS | IWJ | Substantially Equivalent | Best Industries | accessdata.fda.gov |
| January 4, 1991 | K904933 | VARIOUS AFTERLOADING APPLICATORS | IWJ | Substantially Equivalent | Best Assoc. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Source, Brachytherapy, Radionuclide
- All makers of System, Applicator, Radionuclide, Manual
- All makers of System, Applicator, Radionuclide, Remote-Controlled
- All makers of Shield, Eye, Radiological
Updated April 13, 2018. 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.