BEUDAMED
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    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code OAD·May 15, 2014

    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code OAD·November 20, 2015

    Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·December 29, 2011

    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·December 20, 2010

    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·February 4, 2011

    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.

    FDA Recall
    Terminated ·Endologix Inc·Product code OAD·November 25, 2009

    MyRay RXDC dental unit x-ray unit

    FDA Recall
    Terminated ·CEFLA DENTAL GROUP VIA BICOCCA 14/C IMOLA, BO Italy·Product code EHD·August 10, 2012

    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code EHD·January 24, 2014

    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code EHD·January 24, 2014

    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code OAD·May 15, 2014

    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code OAD·November 20, 2015

    PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3

    FDA Recall
    Terminated ·Panoramic Rental Corp.·Product code EHD·July 14, 2017

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia

    FDA Recall
    Terminated ·Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia·Product code KGO·May 23, 2006

    Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia

    FDA Recall
    Terminated ·Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia·Product code KGO·December 18, 2006

    TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

    FDA Recall
    Terminated ·Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom·Product code MWI·March 25, 2011