BEUDAMED
    1,126 results · 22ms · 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 ×

    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code PCU·December 1, 2020

    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code PCU·December 1, 2020

    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code PCU·December 1, 2020

    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code PCU·December 1, 2020

    AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code PCU·December 1, 2020

    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code PCU·December 1, 2020

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·July 21, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·June 29, 2007

    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

    FDA Enforcement
    Class III ·Terminated·Steris Corporation·November 25, 2020

    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

    FDA Recall
    Terminated ·Steris Corporation·Product code FEB·October 7, 2020

    EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

    FDA Enforcement
    Class II ·Terminated·Edan Diagnostics·February 26, 2020

    Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.

    FDA Recall
    Terminated ·Instrumentation Industries Inc·Product code BTO·July 9, 2009

    NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·April 14, 2004

    AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FDI·April 21, 2004

    ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 21, 2008

    NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·April 14, 2004

    NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·April 14, 2004

    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·January 9, 2013

    EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

    FDA Recall
    Terminated ·Edan Diagnostics·Product code MHX·November 17, 2017