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Sign in to claim this brandBeekley Corporation
United States·US-MF-000007055
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1 Prestige Lane, Bristol, United States
- Website
- beekley.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- US-MF-000007055
- FDA FEI Number
- 3000204334
- DUNS Number
- —
Catalogue (161)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GuideLines | 217S | EUDAMEDFDA UDI | Class I | Active |
| GuideLines | 117S | EUDAMEDFDA UDI | Class I | Active |
| TenderTouch | 418S | EUDAMEDFDA UDI | Class I | Active |
| Mr-Spot | 122S | EUDAMEDFDA UDI | Class I | Active |
| Ct-Spot | 120S | EUDAMEDFDA UDI | Class I | Active |
| Rt-Spot | 127S | EUDAMEDFDA UDI | Class I | Active |
| S-Spot | 777S | EUDAMEDFDA UDI | Class I | Active |
| GuideLines | 117 | EUDAMEDFDA UDI | Class I | Active |
| Localizers | 211 | EUDAMEDFDA UDI | Class I | Active |
| Mark-Through GuideLines | 219S | EUDAMEDFDA UDI | Class I | Active |
| S-Spot | 677 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
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Authorities
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 13, 2018 | Z-2832-2018 | — | terminated | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| Jun 13, 2018 | Z-2831-2018 | — | terminated | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| Jun 13, 2018 | Z-2830-2018 | — | terminated | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| May 8, 2017 | Z-2309-2017 | — | terminated | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels |
| Jun 19, 2013 | Z-1787-2014 | — | terminated | Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots |
| Jul 9, 2012 | Z-2112-2012 | — | terminated | Digital Skin Mammography Marker separating from the backing of the spot material |
| Jul 9, 2012 | Z-2109-2012 | — | terminated | Digital Skin Mammography Marker separating from the backing of the spot material |
| Jul 9, 2012 | Z-2111-2012 | — | terminated | Digital Skin Mammography Marker separating from the backing of the spot material |
| Jul 9, 2012 | Z-2110-2012 | — | terminated | Digital Skin Mammography Marker separating from the backing of the spot material |
| Jul 2, 2012 | Z-2080-2012 | — | terminated | Imaging artifact can occur on mammogram result |