Mentor Corp.
United States US-MF-000013525 Last updated 23 Oct 2026
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- Devices
- 216
- Registries
- EUDAMEDFDA 510(k)GUDIDFDA
- FDA recalls
- 0
Catalogue
MENTOR CPX4, Low Height Breast Tissue Expander, Textured Ref 354-8125NW
Silicone Male External Catheter Ref K913524
MENTOR CPX4, Tall Height Breast Tissue Expander, Textured Ref 354-8327NW
MENTOR CPX4, Tall Height Breast Tissue Expander, Textured Ref 354-8323NW
MENTOR CPX4, Medium Height Breast Tissue Expander, Textured Ref 354-8224NW
MENTOR CPX4, Tall Height Breast Tissue Expander, Textured Ref 354-8325NW
MENTOR CPX4, Tall Height Breast Tissue Expander, Textured Ref 354-8322NW
MENTOR CPX4, Medium Height Breast Tissue Expander, Textured Ref 354-8225NW
MENTOR CPX4, Medium Height Breast Tissue Expander, Textured Ref 354-8221NW
MENTOR CPX4, Low Height Breast Tissue Expander, Textured Ref 354-8121NW
MENTOR CPX4, Tall Height Breast Tissue Expander, Textured Ref 354-8321NW
MENTOR CPX4, Low Height Breast Tissue Expander, Textured Ref 354-8124NW
MENTOR CPX4, Medium Height Breast Tissue Expander, Textured Ref 354-8223NW
MENTOR CPX4, Low Height Breast Tissue Expander, Textured Ref 354-8126NW
MENTOR Smooth Round SPECTRUM Saline Breast Implant Ref 350-1440
MENTOR Smooth Round SPECTRUM Saline Breast Implant Ref 350-1450
MENTOR Smooth Round SPECTRUM Saline Breast Implant Ref 350-1410
MENTOR Smooth Round SPECTRUM Saline Breast Implant Ref 350-1480
MENTOR Round High Profile Single Use Saline Breast Implant Sizer Ref 351-3500SZD
Mentor Centerscope Ref 350-4402
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EUDAMED certificates
Notified body 2797 1 certificate
- MDR 740810 Supplemented
Quality management system EU MDR
- Issued
- 25 Jun 2026
- Expires
- 9 Oct 2029
- Reason
- Add device or group
Related companies
Authorised representatives
Notified bodies
- Notified body 2797
What Mentor Corp. makes
Mentor Corp. manufactures breast implants and breast tissue expanders, including saline-filled implants with various profiles (moderate, high, moderate plus) and smooth or textured surfaces, as well as tissue expanders with suture tabs and different heights (low, medium, tall).
The company's devices are classified as Class I, II, III, and IIa, and are listed in regulatory registries including EUDAMED, FDA 510(k), and FDA PMA. Mentor Corp. is based in the United States.
Frequently asked questions
What does Mentor Corp. manufacture?
Mentor Corp. manufactures breast implants and breast tissue expanders, including saline-filled implants with various profiles such as moderate, high, and moderate plus, as well as smooth or textured surfaces, and tissue expanders with suture tabs and different heights like low, medium, and tall.
Where is Mentor Corp. based?
Mentor Corp. is based in the United States, as stated in the provided device data under the COUNTRY field.
Which regulatory registries list Mentor Corp.'s devices?
Mentor Corp.'s devices are listed in regulatory registries including EUDAMED, FDA 510(k), and FDA PMA, as specified in the LISTED IN field of the device data.
How are Mentor Corp.'s devices classified?
Mentor Corp.'s devices are classified as Class I, Class II, Class III, and Class IIa, according to the DEVICE CLASSES field in the provided data.
Information
- Country
- United States
- Address
- 3041, Skyway Circle North, Irving, TX, United States
- Website
- its.jnj.com
- [email protected]
- EUDAMED SRN
- US-MF-000013525
- FDA FEI number
- 1000118360