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System, Applicator, Radionuclide, Manual
FDA product code IWJ · Class 1 · Radiology
2,380
Registered devices
164
Adverse events
11
Recalls
36
510(k) clearances
Devices with this code
Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.SIROS D-Vial Prep Set — SIRTEX MEDICAL PTY LTDBest Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Small Prostate Brachytherapy Kit — Liberty Medical , Inc.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Small Prostate Template — Liberty Medical , Inc.Flexi-Needle — Liberty Medical , Inc.Small Prostate Brachytherapy Kit — Liberty Medical , Inc.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-22 | Sirtex Medical Limited | There is a potential presence of particulate matter in the D-Vial. |
| 2019-02-08 | Riverpoint Medical, LLC | The integrity of the sterile grid packaging is potentially compromised. |
| 2018-10-09 | Theragenics Corporation | Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed |
| 2018-01-09 | Riverpoint Medical, LLC | Product is labeled with "CE", but is not yet approved in the European Union. |
| 2011-08-12 | Worldwide Medical Technologies, LLC | Length of the cannula hub is longer and may not permit a fit with the Applicator |
| 2009-09-01 | Medical Device Technologies, Inc. | Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Ac |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary a |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary a |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary a |
| 2007-11-15 | Alpha Omega Services Inc | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary a |
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