BEUDAMED
    191 results · 13ms · Sources: EU EUDAMED, US FDA

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    Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HEW·June 14, 2019

    Colpo-Pneumo Occluder, Part CPO-6

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

    Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HEW·June 14, 2019

    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·December 30, 2015

    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·March 2, 2016

    Sesame Beginnings Chill & Chew Teether Style #Y3095

    FDA Recall
    Terminated ·RC2 Brands Inc., The First Years·Product code KKO·January 25, 2006

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·July 27, 2016

    Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    FDA Enforcement
    Class II ·Terminated·Straumann Manufacturing, Inc.·January 18, 2017

    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·August 1, 2018

    Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·June 10, 2020

    Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    FDA Enforcement
    Class II ·Terminated·Straumann Manufacturing, Inc.·January 18, 2017

    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·May 13, 2020

    Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    FDA Enforcement
    Class II ·Terminated·Instradent USA, Inc.·December 31, 2014

    Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·May 13, 2020

    Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·May 13, 2020