FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K032644 |
ADAMED LTD. |
KOLPEXIN SPHERE |
05/28/2004 |
K013289 |
BIOTEQUE AMERICA, INC. |
BIOTEQUE VAGINAL PESSARIES |
12/27/2001 |
K060526 |
CONTIPI LTD. |
TIPI |
06/09/2006 |
K131198 |
CONTIPI LTD. |
TIPI OTC |
08/27/2013 |
K190277 |
ConTIPI Medical Ltd. |
ProVate Vaginal Support |
07/08/2019 |
K974117 |
DESCHUTES MEDICAL PRODUCTS, INC. |
PELVX DONUT, PELVX CUBE |
04/27/1998 |
K002329 |
DESCHUTES MEDICAL PRODUCTS, INC. |
PELVX GELLHORN VAGINAL PESSARY 603-608 |
09/18/2000 |
K990593 |
DESCHUTES MEDICAL PRODUCTS, INC. |
PELVX INCONTINENCE DISH, MODEL 301-306 |
05/24/1999 |
K974116 |
DESCHUTES MEDICAL PRODUCTS, INC. |
PELVX INCONTINENCE RING |
04/27/1998 |
K974115 |
DESCHUTES MEDICAL PRODUCTS, INC. |
PELVX RING, PELVX RING WITH SUPPORT |
04/27/1998 |
K083769 |
EASTMED INC. |
MODIFICATION TO URESTA PESSARY |
01/14/2009 |
K081385 |
EASTMED INC. |
URESTA PESSARY |
10/09/2008 |
K132313 |
EIS CORPORATION |
PESSARY |
12/05/2014 |
K965040 |
JOHNSON & JOHNSON MEDICAL, INC. |
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL |
03/10/1997 |
K031463 |
MARINA MEDICAL INSTRUMENTS, INC. |
MARINA MEDICAL SILICONE PESSARY |
11/18/2003 |
K020512 |
MEDICAL TECHNOLOGY AND INNOVATIONS, INC. |
MTI ST#1 SILICONE PESSARY |
05/16/2002 |
K993308 |
MENTOR CORP. |
MENTOR EVACARE VAGINAL PESSARIES |
12/13/1999 |
K153422 |
Panpac Medical Corporation |
Panpac Disposable Pessary Fitting Set |
07/14/2016 |
K173351 |
Panpac Medical Corporation |
Panpac Flexi Shelf Pessary |
10/31/2018 |
K132670 |
Panpac Medical Corporation |
PANPAC INFLATABLE DOCUT PESSARY |
06/04/2014 |
K092981 |
Panpac Medical Corporation |
PANPAC VAGINAL PESSARY |
07/22/2010 |
K151413 |
PROCTER & GAMBLE |
Always/Tampax bladder supports |
12/18/2015 |
K183468 |
Rinovum Subsidiary 2, LLC |
Revive Reusable Bladder Support |
01/25/2019 |
K012277 |
SIMS PORTEX LTD. |
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE |
02/11/2002 |