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Beekley 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: —
EUDAMED SRN: US-MF-000007055
FDA FEI Number: 3000204334
DUNS Number: —

Catalogue (161)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
MarginMap	304S	FDA UDI	Class I	Active
MarginMap	308	FDA UDI	Class I	Active
CaraClip	431	FDA UDI	Class I	Active
CaraClip	431S	FDA UDI	Class I	Active
R-Spot	134	FDA UDI	Class I	Unknown
Mm-Spot	718	FDA UDI	Class I	Active
MarginMap	308S	FDA UDI	Class I	Active
MarginMap	304	FDA UDI	Class I	Active
ColdSPOT	500	FDA UDI	Class I	Active
Amiga	721	FDA UDI	Class I	Unknown
L-Spot	133	FDA UDI	Class I	Active
MR grid	717	FDA UDI	Class I	Active
Bella Blankets	311	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	123	EUDAMEDFDA UDI	Class I	Active
ColdSPOT	505S	EUDAMEDFDA UDI	Class I	Active
InkRight	511	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	123S	EUDAMEDFDA UDI	Class I	Active
MR-SPOT Packets	184S	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	129S	EUDAMEDFDA UDI	Class I	Active
CoreTainer	301	EUDAMEDFDA UDI	Class A	Active
ColdSPOT	500S	EUDAMEDFDA UDI	Class I	Active
R-Spot	113	EUDAMEDFDA UDI	Class I	Active
N-Spot	690	EUDAMEDFDA UDI	Class I	Active
Bella Blankets	310S	EUDAMEDFDA UDI	Class I	Active
N-Spot	653	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	783	EUDAMEDFDA UDI	Class I	Active
PointGuards	115	EUDAMEDFDA UDI	Class I	Active
ColdSPOT	505	EUDAMEDFDA UDI	Class I	Active
N-Spot	632	EUDAMEDFDA UDI	Class I	Active
Bella Blankets	311S	EUDAMEDFDA UDI	Class I	Active
O-Spot	652S	EUDAMEDFDA UDI	Class I	Active
AccuGrid	300	EUDAMEDFDA UDI	Class A	Active
InkRight	511S	EUDAMEDFDA UDI	Class I	Active
Bella	K073262	FDA 510(k)	Class II	Active
Breast Bolster	K020624	FDA 510(k)	Class II	Active
T-Spot	111S	EUDAMEDFDA UDI	Class I	Active
Ortho-SPOT Packets	186	EUDAMEDFDA UDI	Class I	Active
S-Spot	677S	EUDAMEDFDA UDI	Class I	Active
PointGuards	315S	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	135	EUDAMEDFDA UDI	Class I	Active
Localizers	210S	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	783S	EUDAMEDFDA UDI	Class I	Active
L-Spot	112S	EUDAMEDFDA UDI	Class I	Active
InkRight	512S	EUDAMED	Class I	Active
PointGuards	315	EUDAMEDFDA UDI	Class I	Active
PinPoint	128S	EUDAMEDFDA UDI	Class I	Active
AccuGrid	302S	EUDAMEDFDA UDI	Class A	Active
X-Spot	101	EUDAMEDFDA UDI	Class I	Active
PointGuards	316	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	784	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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