BEUDAMED
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    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA

    FDA Enforcement
    Class III ·Terminated·CooperSurgical, Inc.·September 28, 2016

    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

    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·August 25, 2016

    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

    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code LOB·June 3, 2020

    Milex 60cc Handy-Vak Locking Syringe Ref: MX500

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMF·November 1, 2005

    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code LKF·July 3, 2014

    Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code LKF·May 18, 2015

    Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HDX·June 19, 2015

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Quantam 2000 Electrosurgical Generator, Part number 909075-05.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 16, 2019

    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code GAD·September 4, 2018

    CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code GEI·April 30, 2021

    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 of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HHW·September 30, 2014

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 27, 2014

    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code IMD·May 1, 2013

    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code NLM·March 20, 2015

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HDW·May 20, 2015

    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 support defects and stress urinary incontinence.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HHW·September 14, 2015