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Sign in to claim this brandDevicor 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
Information
- Country
- United States
- Address
- 300, E. Business Way, Cincinnati, United States
- Website
- www.mammotome.com
- —
- —
- [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
- CEpartner4U NL
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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.
| 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. |