544 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·February 19, 2014
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·February 19, 2014
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·March 25, 2020
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·January 11, 2017
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm. PT Graphix Magnet is available with a shapeable Straight Tip or a preformed "J"¿ Tip. The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·April 20, 2016
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·October 3, 2012
ACCOLADE SR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
PROPONENT DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ACCOLADE DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
PROPONENT SR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ESSENTIO SR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ESSENTIO DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
PROPONENT EL DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ESSENTIO MRI SR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ACCOLADE MRI DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ALTRUA 2 SR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
VALITUDE CRT-P Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ACCOLADE EL DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ACCOLADE MRI SR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
ESSENTIO EL DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018