BEUDAMED
    44 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    Quantam 2000 Electrosurgical Generator, Part number 909075.

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·December 11, 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 Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·October 3, 2018

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 23, 2018

    NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

    Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

    MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

    Colpo-Pneumo Occluder, Part CPO-6

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·October 17, 2018

    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 Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·July 15, 2020

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·June 24, 2015

    CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·July 1, 2015

    Quantam 2000 Electrosurgical Generator, Part number 909075-05W.

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

    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, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 10, 2021

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

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·September 17, 2014

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

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 27, 2015

    Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·July 29, 2015

    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 Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 15, 2015

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015