Data / Medical devices / United States / Beekley Corporation
Beekley Corporation: FDA-registered device maker in Bristol, CT, United States, 1 510(k) clearance
Beekley Corporation is registered with the FDA (registration 9021987) in Bristol, CT, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2008. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9021987
- FEI number
- 3000204334
- Address
- 1 Prestige LN, Bristol, CT, United States, 06010
- Owner or operator
- Beekley Corporation (10023165)
- Roles
- Manufacturer
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- AccuGrid, Altus, Bella Blankets, ColdSPOT, CoreTainer, Cradles, GuideLines, InkRight and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Grid, Radiographic | IXJ | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | accessdata.fda.gov |
| Specimen/Tissue, Identification Orientation | MJI | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Film Marking, Radiographic | JAC | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mammographic | IZH | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 26, 2008 | K073262 | BELLA | IZH | Substantially Equivalent | Beekley Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 13, 2018 | 80558 | Class II | Terminated | O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. | There is a potential for imaging artifact to mimic calcifications on patient's mammograms | accessdata.fda.gov |
| May 8, 2017 | 77295 | Class III | Terminated | Beekley Medical 0-SPOT Mammography Skin Markers REF 652 | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels | accessdata.fda.gov |
| June 19, 2013 | 65483 | Class III | Terminated | Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography | Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots | accessdata.fda.gov |
| July 9, 2012 | 62526 | Class II | Terminated | Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern | Digital Skin Mammography Marker separating from the backing of the spot material | accessdata.fda.gov |
| July 2, 2012 | 62432 | Class II | Terminated | Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging recept | Imaging artifact can occur on mammogram result | accessdata.fda.gov |
Compare with other makers
- All makers of Grid, Radiographic
- All makers of System, X-Ray, Mammographic
- All makers of System, X-Ray, Film Marking, Radiographic
- All makers of Specimen/Tissue, Identification Orientation
- All makers of Tape And Bandage, Adhesive
- All makers of Pack, Hot Or Cold, Disposable
Updated March 26, 2008. 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.