BEUDAMED
    39 results · 11ms · Sources: EU EUDAMED, US FDA

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    Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Quantam 2000 Electrosurgical Generator, Part number 909075-05.

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

    Fischer Cone Biopsy Excisor Model: 900-158

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Small Model: 900-150

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    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

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

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·March 12, 2018

    Fischer Cone Biopsy Excisor - Medium Model: 900-151

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·June 18, 2019

    Quantam 2000 Electrosurgical Generator, Part number 909075.

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

    Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.

    FDA Recall
    Terminated ·Gynex Corporation·Product code HGI·September 6, 2012

    Fischer Cone Biopsy Excisor Model: 900-157

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

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

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

    Fischer Cone Biopsy Excisor - Large Model: 900-152

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·April 23, 2019

    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

    FDA Recall
    Terminated ·Ameda, Inc.·Product code HGY·February 12, 2015

    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

    FDA Recall
    Terminated ·Ameda, Inc.·Product code HGY·February 12, 2015

    Multitom RAX with software version VF10

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021

    Multitom RAX with software version VF10

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021