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    Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code DXY·November 29, 2005

    Discovery II Multiprogrammable Pacemaker, Model 1284

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·June 23, 2003

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code DXY·August 28, 2017

    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Recall
    Completed ·STRATASYS LTD·Product code EBI·January 19, 2024

    Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·May 18, 2009

    Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    Discovery Multiprogrammable Pacemaker, DDDR Model 1273

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Pulsar Multiprogrammable Pacemaker, DDDR Model 1272

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package

    FDA Recall
    Terminated ·Lang Dental Mfg Co, Inc.·Product code EBI·June 7, 2004

    Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code DXY·February 11, 2010

    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base

    FDA Recall
    Terminated ·CMP Industries, Llc·Product code EBI·March 2, 2016

    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Recall
    Completed ·STRATASYS LTD·Product code EBI·January 19, 2024

    Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256

    FDA Recall
    Terminated ·Product code DXY·November 4, 2002

    Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    Pulsar Max II Multiprogrammable Pacemaker, Model 1180

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·June 23, 2003

    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.

    FDA Recall
    Terminated ·CMP Industries, Llc·Product code EBI·November 18, 2013

    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

    FDA Recall
    Terminated ·CMP Industries, Llc·Product code EBI·April 28, 2016

    Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    FDA Recall
    Terminated ·CMP Industries, Llc·Product code EBI·September 12, 2018

    Merlin PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022