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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 3 of 4

Device	Model / Reference	Registries	Class	Status
T-Spot	111	EUDAMEDFDA UDI	Class I	Active
PointGuards	316S	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	785S	EUDAMEDFDA UDI	Class I	Active
N-Spot	790S	EUDAMEDFDA UDI	Class I	Active
Mr-Spot	121S	EUDAMEDFDA UDI	Class I	Active
CoreTainer	301S	EUDAMEDFDA UDI	Class A	Active
Z-Spot	114S	EUDAMEDFDA UDI	Class I	Active
Pinnacle	330	EUDAMEDFDA UDI	Class I	Active
N-Spot	732S	EUDAMEDFDA UDI	Class I	Active
N-Spot	790PS	EUDAMEDFDA UDI	Class I	Active
X-Spot	101S	EUDAMEDFDA UDI	Class I	Active
V-Spot	603S	EUDAMEDFDA UDI	Class I	Active
S-Spot	650S	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	129	EUDAMEDFDA UDI	Class I	Active
PinPoint	187S	EUDAMEDFDA UDI	Class I	Active
X-Spot	601	EUDAMEDFDA UDI	Class I	Active
PointGuards	318	EUDAMEDFDA UDI	Class I	Active
X-Spot	601S	EUDAMEDFDA UDI	Class I	Active
N-Spot	732	EUDAMEDFDA UDI	Class I	Active
N-Spot	632S	EUDAMEDFDA UDI	Class I	Active
N-Spot	610S	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	785	EUDAMEDFDA UDI	Class I	Active
CoreTainer	303	EUDAMEDFDA UDI	Class A	Active
Localizers	210	EUDAMEDFDA UDI	Class I	Active
N-Spot	790	EUDAMEDFDA UDI	Class I	Active
Rt-Spot	130	EUDAMEDFDA UDI	Class I	Active
AccuGrid	302	EUDAMEDFDA UDI	Class A	Active
Y-Spot	102S	EUDAMEDFDA UDI	Class I	Active
Y-Spot	602S	EUDAMEDFDA UDI	Class I	Active
Localizers	211S	EUDAMEDFDA UDI	Class I	Active
O-Spot	691S	EUDAMEDFDA UDI	Class I	Active
Mr-Spot	122	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	118	EUDAMEDFDA UDI	Class I	Active
TomoSPOT	782S	EUDAMEDFDA UDI	Class I	Active
PinPoint	187	EUDAMEDFDA UDI	Class I	Active
PinPoint	128	EUDAMEDFDA UDI	Class I	Active
ColdSPOT	502	EUDAMEDFDA UDI	Class I	Active
ColdSPOT	502S	EUDAMEDFDA UDI	Class I	Active
Mark-Through GuideLines	219	EUDAMEDFDA UDI	Class I	Active
PointGuards	318S	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	119S	EUDAMEDFDA UDI	Class I	Active
PointGuards	215S	EUDAMEDFDA UDI	Class I	Active
Ortho-SPOT Packets	186S	EUDAMEDFDA UDI	Class I	Active
GuideLines	217	EUDAMEDFDA UDI	Class I	Active
Y-Spot	102	EUDAMEDFDA UDI	Class I	Active
R-Spot	113S	EUDAMEDFDA UDI	Class I	Active
L-Spot	112	EUDAMEDFDA UDI	Class I	Active
Ct-Spot	120	EUDAMEDFDA UDI	Class I	Active
MR-SPOT Packets	185	EUDAMEDFDA UDI	Class I	Active
Cradles	309S	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