Beekley Corporation

Bristol, CT, US

Beekley Corporation appears in FDA device records in Bristol, CT. FDA records list 2 510(k) clearances between 2002-09-12 and 2008-03-26, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 10 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 10
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Beekley Corporation between 2002 and 2008. The busiest year on record is 2002, with 1. The most recent is 2008, with 1.

Clearances by year, as a table

510(k) clearance decisions for Beekley Corporation, by decision year
Year	Clearances
2002	1
2008	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K073262	BELLA	IZH	Substantially Equivalent	2008-03-26
K020624	BREAST BOLSTER	IZH	Substantially Equivalent	2002-09-12

Registered establishments

FDA registered establishments for Beekley Corporation, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9021987	3000204334	Beekley Corporation	1 PRESTIGE LN, Bristol, CT 06010 US	2026	FZZ IMD IXJ IZH JAC KGX MJI NNI

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2832-2018	TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.	There is a potential for imaging artifact to mimic calcifications on patient's mammograms	Class II	2018-06-13	Terminated
Z-2831-2018	S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.	There is a potential for imaging artifact to mimic calcifications on patient's mammograms	Class II	2018-06-13	Terminated
Z-2830-2018	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	Class II	2018-06-13	Terminated
Z-2309-2017	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	Class III	2017-05-08	Terminated
Z-1787-2014	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	Class III	2013-06-19	Terminated
Z-2112-2012	Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain	Digital Skin Mammography Marker separating from the backing of the spot material	Class II	2012-07-09	Terminated
Z-2111-2012	Beekley O-Spots Floral Skin Markers -Order Number: 752 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	Class II	2012-07-09	Terminated
Z-2110-2012	Beekley A-Spots Floral Skin Markers -Order Number: 751 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	Class II	2012-07-09	Terminated
Z-2109-2012	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	Class II	2012-07-09	Terminated
Z-2080-2012	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 receptor plate.	Imaging artifact can occur on mammogram result	Class II	2012-07-02	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain