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)
Top companies in HHW
| Company | 510(k)s | Recalls |
|---|---|---|
| Cooper Surgical | 1 | 9 |
| CooperSurgical, Inc. | 1 | 6 |
| Deschutes Medical Products, Inc. | 5 | 0 |
| Panpac Medical Corporation | 4 | 0 |
| Bioteque America, Inc. | 3 | 0 |
| Johnson & Johnson Medical, Inc. | 3 | 0 |
| Contipi , Ltd. | 2 | 0 |
| Eastmed, Inc. | 2 | 0 |
| Milex Products, Inc. | 2 | 0 |
| Adamed , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4"
Catalog # MXPCON06 Open, Classified |
HHW | K904774 |
| Feb 26, 2021 | CooperSurgical, Inc. Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2 Terminated |
HHW | K904774 |
| May 2, 2019 | Rinovum Women's Health Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women Terminated |
HHW | K183468 |
| Apr 10, 2017 | CooperSurgical, Inc. CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit.
Product Usage:
The lnflatoball Pessary is a single-patient use pessary manufac Terminated |
HHW | K904026 K904774 |
| Nov 10, 2015 | CooperSurgical, Inc. MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07
Product Usage:
The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic su Terminated |
HHW | K904774 |
| Mar 3, 2015 | CooperSurgical, Inc. CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm
Part Number: MXKPEC02 Terminated |
HHW | K904026 |
| Nov 13, 2014 | CooperSurgical, Inc. CooperSurgical MILEX PESSARY KITS-
Hodge w/Support Folding Pessary- #1
Model: MXKPHS01
Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number Terminated |
HHW | K904026 K904774 |
| Nov 13, 2014 | CooperSurgical, Inc. CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1
Model: MXKPRS01
Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number o Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex
Part Number: MXKPECH00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the ute Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Cube Pessary 1 5/8"", 41mm.
Milex
Part Number: MXKPEC04
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or blad Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex
Part Number: MXPGE3-
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/o Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex
Part Number: MXPGE2-3/4
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uter Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex
Part Number: MXPCOND00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the ut Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex
Part Number: MXKPCOND00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the u Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex
Part Number: MXKPCONDS00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of t Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex
:Part Number: MXPCONDS05
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of t Terminated |
HHW | K904026 K904774 |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex
Part Number: MXPCON04
A pessary is a medical device that is inserted into the vagina to function as a supportive structure o Terminated |
HHW | K904026 K904774 |
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