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

    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·July 30, 2025

    HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·July 30, 2025

    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·July 30, 2025

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·October 2, 2024

    Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·October 2, 2024

    Stainless Steel Sims Uterine Sound, Part Number 64-601

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·October 2, 2024

    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·October 2, 2024

    Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·October 2, 2024

    Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·February 14, 2024

    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 13, 2023

    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 13, 2023

    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 13, 2023

    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·April 12, 2023