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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

DateFirm and productCodeLinked 510(k)
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
Open, Classified
HHWK904774
Feb 26, 2021CooperSurgical, 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
HHWK904774
May 2, 2019Rinovum 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
HHWK183468
Apr 10, 2017CooperSurgical, 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
HHWK904026
K904774
Nov 10, 2015CooperSurgical, 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
HHWK904774
Mar 3, 2015CooperSurgical, Inc.
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Terminated
HHWK904026
Nov 13, 2014CooperSurgical, 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
HHWK904026
K904774
Nov 13, 2014CooperSurgical, 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774
Mar 27, 2013Cooper 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
HHWK904026
K904774

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