FDA.report

MENTOR

Matched from indexed company URL: Mentor Corp.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16453371000118360MENTOR1N2026-01-013041 SKYWAY CIRCLE NORTH IRVING TX US 75038
30054235193006165545Mentor Texas LP1N2026-01-01555 Airline Drive Coppell TX US 75019
30278480943027848094MENTOR SUPPLY CHAIN (USA) INC1N2026-01-011395 POLK DRIVE Warsaw IN US 46582

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
10081317031052MENTOR MemoryGel Enhance Breast Implant - Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1030cc+1(800)235-5731xx@xx.xx
10081317031069MENTOR MemoryGel Enhance Breast Implant - Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1135cc+1(800)235-5731xx@xx.xx

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
355911661375709P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESFWM2000-05-10
861921661375709P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESFWM2000-05-10
355911608985162P060028MENTOR MEMORYSHAPE BREAST IMPLANTSFTR2013-06-14
861921608985162P060028MENTOR MEMORYSHAPE BREAST IMPLANTSFTR2013-06-14
355912064789343P030053MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTSFTR2006-11-17
861922064789343P030053MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTSFTR2006-11-17
355911152051327K981527MENTOR PATHWAY INTRODUCER/DILATORQPB1998-07-09
355911066584809K981215PSI-TEC LIPOSUCTION ASPIRATORQPB1998-07-01
355911007830419K981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESQPB1998-06-30
355911068961882K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGKGZ1998-02-10
355911612581036K842883RADOVAN TISSUE EXPANDERLCJ1984-08-17
861921612581036K842883RADOVAN TISSUE EXPANDERLCJ1984-08-17
355912044373264K780417ASEPTIC TRANSFER SETGAZ1978-04-18
355911481002702K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderLCJ2025-01-12
861921481002702K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderLCJ2025-01-12
861921419930633K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2025-01-13
355911419930633K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2025-01-13
861921830762334K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderLCJ2024-08-02
355911830762334K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderLCJ2024-08-02
355911942608549K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2024-09-06
861921942608549K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2024-09-06
861921424363314K201115Next Generation Balloon Dilation SystemLRC2020-08-27
861921926523184K182335CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ2018-09-25
355911926523184K182335CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ2018-09-25
3220471446652414K172205ExoToe StapleJDR2018-01-11
355911661589037K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceLCJ2016-05-23
861921661589037K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceLCJ2016-05-23
861921675414805K153341Relieva Scout Multi-Sinus Dilation SystemLRC2016-02-12
355911208373202K152496CPX 4 Breast Tissue ExpanderLCJ2016-02-19
861921208373202K152496CPX 4 Breast Tissue ExpanderLCJ2016-02-19
861921088484147K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRD2015-05-20
355911088484147K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRD2015-05-20
355911756760441K150777Artoura Breast Tissue ExpanderLCJ2015-04-24
861921756760441K150777Artoura Breast Tissue ExpanderLCJ2015-04-24
861921830897408K150172ACCLARENT SE Inflation DeviceLRC2015-04-07
861921525702657K143541Relieva SpinPlus Balloon Sinuplasty SystemLRC2015-04-22
355911721940518K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMRD2013-07-17
861921721940518K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMRD2013-07-17
861921397547108K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSLCJ2013-04-11
355911397547108K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSLCJ2013-04-11
861921943803725K120280RELIEVA SEEKER BALLOON SINUPLASTY SYSTEMLRC2012-11-05
861921465178039K111875RELIEVA SPIN SINUS DILATION SYSTEMLRC2011-10-11
861922002504728K111254RELIEVA SOLO ELITE SINUS BALLOON CATHETERLRC2011-08-22
861921259394191K110218INSPIRA AIR BALLOON DILATION SYSTEMKTI2011-03-31
861921554264187K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEEOB2011-05-27
861921522441595K090660AIRWAY BALLOON CATHETER INFLATION DEVICEKTI2009-06-12
861921937655283K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AKAM2007-09-28
861921448135728K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMRD2006-10-10
355911448135728K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMRD2006-10-10
861921146363971K052198RELIEVA SINUS BALLOON INFLATION DEVICELRC2005-08-31
355911809214721K040149PSI-TEC PERISTALTIC INFILTRATION PUMPFRN2004-06-03
861921135638949K011500MENTOR CONTOUR PROFILE TISSUE EXPANDERLCJ2001-12-03
355911135638949K011500MENTOR CONTOUR PROFILE TISSUE EXPANDERLCJ2001-12-03
861921297965014K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMRD2001-04-23
355911297965014K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMRD2001-04-23
355911506150906K001803ACCELERATOR RECIPROCATING CANNULAQPB2000-08-04
861921271146102DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemPNZ2016-09-16
861921151220819
861921600821666
355911700198888
861921793744659
861922073649606

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LCJ182025-01-12
MRD122025-01-13
LRC82020-08-27
FTR42013-06-14
QPB42000-08-04
KTI22011-03-31
FWM22000-05-10
JDR12018-01-11
PNZ12016-09-16
EOB12011-05-27
KAM12007-09-28
FRN12004-06-03
KGZ11998-02-10
GAZ11978-04-18

PMA

Spectrum Breast Implants

2022-11-16

MENTOR WORLDWIDE LLC33 Technology Driveirvine, CA 92618 PMA NumberP990075 Supplement NumberS054 Date Received05/10/2022 Decision Date11/16/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice ...

MENTOR MemoryShape Breast Implants

2022-03-08

MENTOR WORLDWIDE LLC33 Technology Driveirvine, CA 92618 PMA NumberP060028 Supplement NumberS044 Date Received02/04/2022 Decision Date03/08/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track No User Fee Su...

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PMN

100 records. Showing 1-40. Next

GUDID

80 records. Showing 1-40. Next