BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·July 29, 2011

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.

    FDA Recall
    Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery Division.

    FDA Recall
    Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

    Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code KNF·February 12, 2013

    Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

    FDA Recall
    Terminated ·CARESTREAM DENTAL, LLC·Product code NOF·February 15, 2021

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.

    FDA Recall
    Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

    Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.

    FDA Recall
    Terminated ·Integra Limited·Product code KNF·May 23, 2012

    Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

    FDA Recall
    Terminated ·The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square·Product code FWZ·June 2, 2003

    HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007

    Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.

    FDA Recall
    Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004

    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code KRA·August 10, 2005

    EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code KNT·June 17, 2008

    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine

    FDA Recall
    Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004

    Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQO·June 4, 2007

    Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code LOX·May 1, 2007

    Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQO·October 12, 2007

    Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

    Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-1225 Use before 2007-01 UPN H7493892812250 Sterilized with ethylene oxide gas Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-2035 Use before 2007-01 UPN H7493892820350 Sterilized with ethylene oxide gas Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code LOX·November 1, 2005

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Recall
    Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016