Mentor Corp.
United States US-MF-000013525 Last updated 25 Oct 2026
- Devices
- 233
- Registries
- EUDAMEDGUDIDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
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
Mentor Suspend Sling Ref K980483
Mentor Ductal Catheters Ref K895285
Gastroplasty Calibrating Tube & Gastrostenometer Ref K874690
Mentor Flat-Span Ref K862049
Mentor Ultrasound-Assisted Tissue Removal System Ref K983065
Mentor Corporal Dilators Ref K860517
Mentor Universal Ureteral Stent Set Ref K851870
Mentor Tissue Expanders W/Tdmac Coating Ref K894475
Mentor Injection Port Detector (Ipd) Ref K963066
Mentor Obtape Trans-Obturator Tape Ref K031767
Mentor Obtape Trans-Obturator Surgical Kit Ref K042851
Mentor Percutaneous Renal Dilator Set Ref K850355
Stimulator, Mentor 100 Nerve Ref K790011
Mentor Self-Cath Closed System Ref K003873
Mentor Self-Cath Plus Ref K003784
Ultra-Fresh Deodorant Ref K871313
Modified Ultra-Fresh Odor Reducing Compound Ref K883023
Mentor Aris Suprapubic Surgical Kit Ref K053296
Mentor Phacoemulsification Sistem Remote Control Ref K974469
Silicone Double Coil Ureteral Stent With Suture Ref K862539
Mentor Self-Cath Hydrogel Intermittent Catheter Ref K050008
Mentor Contour Profile Tissue Expander Ref K011500
Mentor Single Coil Urinary Diversion Stent Set Ref K860055
Female Urine Sampling Device Ref K922346
Mentor Black Light Injection Stent Set Ref K912060
Mentor Percutaneous Malecot Nephrostomy Set Ref K850287
Showing 51-100 of 233
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