Cooper Surgical, Inc.

Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

FDA Enforcement

Class III ·Terminated·CooperSurgical, Inc.·April 22, 2020

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

FDA Recall

Terminated ·CooperSurgical, Inc.·Product code LKF·May 13, 2014

Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

FDA Recall

Terminated ·CooperSurgical, Inc.·Product code MFD·February 28, 2020

DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code KGI·September 23, 2011

Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System Model: 900034.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009

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 the uterus and/or bladder and rectum.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HHW·February 26, 2013

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 uterus and/or bladder and rectum.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HHW·February 26, 2013

LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code MQB·February 26, 2013

Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System Model: 900010.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009

Wallach LL100 Cryosurgical Freezer Atom CO2 System Model: 900036.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009

Wallach LL100 Cryosurgical Freezer CO2 System Model: 9000002X.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009

Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HDB·January 16, 2008

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 uterus and/or bladder and rectum.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HHW·February 26, 2013

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 of the uterus and/or bladder and rectum.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HHW·February 26, 2013

Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code LKF·October 31, 2012

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HDW·February 26, 2013

M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HDB·January 16, 2008

M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HDB·January 16, 2008

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 the uterus and/or bladder and rectum.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code HHW·February 26, 2013

WA 4000 Console Model: 900509x.

FDA Recall

Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009