BEUDAMED
    143 results · 40ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    FDA Recall
    Terminated ·Catheter Connections, Inc.·Product code LKB·August 5, 2014

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    FDA Enforcement
    Class II ·Terminated·Catheter Connections, Inc.·September 17, 2014

    Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainage bag

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009

    Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009

    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

    FDA Enforcement
    Class I ·Terminated·Hummingbird Med·June 1, 2016

    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 27, 2009

    Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·April 14, 2008

    Model 8596SC Intrathecal Catheter Pump Segment Revision Kit Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·April 14, 2008

    Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·April 14, 2008

    Medtronic 8578 Sutureless Pump Connector Revision Kit Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·April 14, 2008

    Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage.

    FDA Recall
    Terminated ·Enpath Medical, Inc.·Product code DYB·August 31, 2005

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011

    HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·May 23, 2011