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Devicor Medical Products, Inc.

United States·US-MF-000003322

Last updated September 17, 2026

About

Mammotome and Sirius Medical announce Health Canada approval for the Pintuition® System, expanding access across the country.

From the manufacturer's own website. Source

What Devicor Medical Products, Inc. makes

Devicor Medical Products, Inc. manufactures mammographic stereotactic biopsy systems, vacuum-assisted breast biopsy systems, and implantable radiological image markers. The company also produces side-notch biopsy gun handpieces, nuclear medicine systems, needle guides, collimators, and single-use patient surgical drapes.

The company is based in the United States, and its portfolio includes devices classified as Class I, Class II, and Class IIa. These products are listed in the FDA 510(k) and UDI databases, as well as the EUDAMED registry.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 300, E. Business Way, Cincinnati, United States
Website: www.mammotome.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: John Cummings
EUDAMED SRN: US-MF-000003322
FDA FEI Number: 3008492462
DUNS Number: —

Catalogue (273)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Mammotome revolve MammoMark	MMK1001	FDA UDI	Class II	Active
HydroMark	4010-01-08-S1	FDA UDI	Class II	Unknown
Mammotome	MHH8	FDA UDI	Class II	Unknown
HydroMark	4010-04-09-T4	FDA UDI	Class II	Unknown
Mammotome MAMMOMARK 2	MAM3008	FDA UDI	Class II	Active
Mammotome	MVAC1	FDA UDI	Class II	Active
HydroMark	4010-02-15-T3	FDA UDI	Class II	Unknown
Mammotome Revolve EX	MHEX08S	EUDAMEDFDA UDI	Class II	Active
Mammotome	MHH14	FDA UDI	Class II	Unknown
Neoprobe	NPB10A	FDA UDI	Class I	Active
HydroMark	4010-02-15-T4	FDA UDI	Class II	Unknown
Mammotome CORMARK	MAM3015	FDA UDI	Class II	Active
Mammotome revolve	MSCM1	FDA UDI	Class II	Active
Mammotome ST	MST11B	FDA UDI	Class II	Active
LumiMARK Breast Biopsy Site Marker	LMO215L	FDA UDI	Class II	Active
HydroMark	4010-04-09-T1	FDA UDI	Class II	Active
Mammotome	MRLB1	FDA UDI	Class II	Unknown
Mammotome MammoTest	G1621	FDA UDI	Class II	Active
Mammotome	G011F	FDA UDI	Class II	Active
neoprobe	NPA75	FDA UDI	Class I	Active
Mammotome MR	MRK303	FDA UDI	Class II	Unknown
Mammotome revolve	MHUSH1	EUDAMEDFDA UDI	Class II	Active
HydroMark	4010-01-08-T4	FDA UDI	Class II	Active
Mammotome HydroMARK	4010-05-10-T4	FDA UDI	Class II	Active
Mammotome MicroMark II	C1540	FDA UDI	Class II	Active
Mammotome MammoTest	MMT100	FDA UDI	Class II	Active
Mammotome revolve	MHKEYP1	FDA UDI	Class II	Active
Mammotome MI	ADT08S	FDA UDI	Class II	Unknown
Mammotome MR	MRP11S	FDA UDI	Class II	Active
Mammotome	SCMC1	FDA UDI	Class II	Active
Mammotome HydroMARK	4010-05-08-T4	FDA UDI	Class II	Active
Mammotome	SCM12	FDA UDI	Class II	Active
HydroMARK Breast Biopsy Site Marker	4010-02-15-T4	FDA UDI	Class II	Active
neoprobe	NPR14	FDA UDI	Class I	Active
neoprobe	NPB11L	FDA UDI	Class I	Active
neoprobe	NPB11L	FDA UDI	Class I	Active
Mammotome MAMMOMARK 2	MAM3002	FDA UDI	Class II	Active
HydroMark	4010-02-15-T1	FDA UDI	Class II	Active
Mammotome Revolve EX	MHEXH1	EUDAMEDFDA UDI	Class II	Active
Mammotome EX	HH11BEX	FDA UDI	Class II	Active
neoprobe	NPB14A	FDA UDI	Class I	Active
Mammotome CORMARK	MAM3014	FDA UDI	Class II	Active
neoprobe	NPB09S	FDA UDI	Class I	Active
Mammotome MI	ADP08S	FDA UDI	Class II	Unknown
neoprobe	NAP76	FDA UDI	Class I	Active
neoprobe	NPB14S	FDA UDI	Class I	Active
Control Module- Revolve EX	MSCM1	EUDAMEDFDA UDI	Class II	Active
Mammotome MAMMOMARK	MRM4008	FDA UDI	Class II	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEP13	EUDAMEDFDA UDI	Class IIa	Active
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System	MEH1	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Devicor Medical Products, Inc. has 5 recall records initiated between 2016-05-19 and 2026-04-24, which are currently in open, classified, or terminated statuses. The reasons for these recalls include incorrect inner package labeling, mismatches between patient and primary device labels, missing product information on device labeling, shipping discrepancies regarding needle gauge and length, and software version documentation inconsistencies.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 24, 2026	Z-2239-2026	—	open, classified	Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Mar 30, 2022	Z-1124-2022	—	terminated	Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Sep 7, 2020	Z-0070-2021	—	terminated	It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Feb 28, 2017	Z-1512-2017	—	terminated	The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
May 19, 2016	Z-2211-2016	—	terminated	A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.