BEUDAMED
    78 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    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

    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·January 22, 2020

    Quantam 2000 Electrosurgical Generator, Part number 909075-05.

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·December 11, 2019