ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HHW · Class 2

Pessary, Vaginal

Regulation 884.3575

1510(k)s in 12 months (41 all time)
0recalls in 12 months (17 all time)
17recalls that name a 510(k)
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Top companies in HHW

Company510(k)sRecalls
Cooper Surgical19
CooperSurgical, Inc.16
Deschutes Medical Products, Inc.50
Panpac Medical Corporation40
Bioteque America, Inc.30
Johnson & Johnson Medical, Inc.30
Contipi , Ltd.20
Eastmed, Inc.20
Milex Products, Inc.20
Adamed , Ltd.10
Decided510(k)Device and applicantCode
Jan 20, 2026K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube
Cooper Surgical
HHW
Apr 11, 2025K250438CooperSurgical Milex® Pessaries
CooperSurgical, Inc.
HHW
Dec 17, 2024K240798Cntrl+ Bladder Support Pessary
Cntrl+, Inc., CA
HHW
May 21, 2024K232677Reia pessary
Reia, LLC
HHW
May 17, 2024K232525Yoni.Fit Bladder Support
Watkins-Conti Products, Inc.
HHW
Apr 3, 2024K233548Uresta®
Resilia, Inc., CA
HHW
Mar 6, 2024K231786Gynethotics™ Pessary
Cosm Medical, CA
HHW
Jul 8, 2019K190277ProVate Vaginal Support
Contipi Medical , Ltd., IL
HHW
Jan 25, 2019K183468Revive Reusable Bladder Support
Rinovum Subsidiary 2, LLC
HHW
Oct 31, 2018K173351Panpac Flexi Shelf Pessary
Panpac Medical Corporation, TW
HHW
Jul 14, 2016K153422Panpac Disposable Pessary Fitting Set
Panpac Medical Corporation, TW
HHW
Dec 18, 2015K151413Always/Tampax bladder supports
Procter & Gamble
HHW
Dec 5, 2014K132313PESSARY
Eis Corporation, KR
HHW
Jun 4, 2014K132670PANPAC INFLATABLE DOCUT PESSARY
Panpac Medical Corporation, TW
HHW
Aug 27, 2013K131198TIPI OTC
Contipi , Ltd.
HHW
Jul 22, 2010K092981PANPAC VAGINAL PESSARY
Panpac Medical Corporation, TW
HHW
Jan 14, 2009K083769MODIFICATION TO URESTA PESSARY
Eastmed, Inc., CA
HHW
Oct 9, 2008K081385URESTA PESSARY
Eastmed, Inc., CA
HHW
Jun 9, 2006K060526TIPI
Contipi , Ltd.
HHW
May 28, 2004K032644KOLPEXIN SPHERE
Adamed , Ltd.
HHW
Nov 18, 2003K031463MARINA MEDICAL SILICONE PESSARY
Marina Medical Instruments, Inc.
HHW
May 16, 2002K020512MTI ST#1 SILICONE PESSARY
Medical Technology and Innovations, Inc.
HHW
Feb 11, 2002K012277PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
Sims Portex , Ltd., GB
HHW
Dec 27, 2001K013289BIOTEQUE VAGINAL PESSARIES
Bioteque America, Inc.
HHW
Sep 18, 2000K002329PELVX GELLHORN VAGINAL PESSARY 603-608
Deschutes Medical Products, Inc.
HHW
Dec 13, 1999K993308MENTOR EVACARE VAGINAL PESSARIES
Mentor Corp.
HHW
May 24, 1999K990593PELVX INCONTINENCE DISH, MODEL 301-306
Deschutes Medical Products, Inc.
HHW
Apr 27, 1998K974117PELVX DONUT, PELVX CUBE
Deschutes Medical Products, Inc.
HHW
Apr 27, 1998K974116PELVX INCONTINENCE RING
Deschutes Medical Products, Inc.
HHW
Apr 27, 1998K974115PELVX RING, PELVX RING WITH SUPPORT
Deschutes Medical Products, Inc.
HHW
Mar 10, 1997K965040INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
Johnson & Johnson Medical, Inc.
HHW
May 4, 1995K933654BLADDER NECK SUPPORT PROTHESIS FITTING KIT
Johnson & Johnson Medical, Inc.
HHW
May 4, 1995K930618VAGINAL CONTINENCE DEVICE
Johnson & Johnson Medical, Inc.
HHW
Aug 29, 1994K920747PESSARY FLEXIBLE SILICONE DONUT RING
Bioteque America, Inc.
HHW
Oct 23, 1992K920187FLEXIBLE SILICONE GELIHORN
Bioteque America, Inc.
HHW
Dec 7, 1990K904774INGLAT-O-BALL
Milex Products, Inc.
HHW
Oct 10, 1990K904026INFLAT-O-BALL
Milex Products, Inc.
HHW
Mar 29, 1989K890565GELLHORN PESSARY 33410 VARIOUS SIZES
Medi-Source, Inc.
HHW
Oct 3, 1988K883721FEMALE CONTINENCE DEVICE
Cook Ob/Gyn
HHW
Nov 6, 1978K781863DEVICE, FEMALE INCONTINENCE
Eschmann Bros. & Walsh , Ltd.
HHW
Nov 7, 1977K771548SILASTIC BRAND INTRAVAGINAL TARSETTE
Dow Corning Corp. Healthcare Industries Materials
HHW

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