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Cradle, BK 8551
Best Nomos · Model 6057 · UDI-DI 00852656007120
1
510(k) clearances
164
Adverse events
11
Recalls
46
Facilities
Description
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
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 Access Needles, Bone B |
| 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 and possibly contamin |
| 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 and possibly contamin |
| 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 and possibly contamin |
| 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 and possibly contamin |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.