BEUDAMED
    172 results · 10ms · Sources: EU EUDAMED, US FDA

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    Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001182830 18-283 11961001 RENEGADE HI FLO 80/20 M001182840 18-284 11294909 RENEGADE HI FLO 105/10 M001182850 18-285 12703162 RENEGADE HI FLO 105/20 M001182860 18-286 11339895 RENEGADE HI FLO 115/10 M001182870 18-287 12669789 RENEGADE HI FLO 115/20 M001182880 18-288 11295844 RENEGADE HI FLO 135/10 M001182890 18-289 12703088 RENEGADE HI FLO 135/20 M001182900 18-290 11295637 RENEGADE HI FLO 150/10 M001182910 18-291 12684437 RENEGADE HI FLO 150/20 M001182980 18-298 11320970 RENEGADE HI FLO 105/10 KIT M001182990 18-299 12721456 RENEGADE HI FLO 105/20 KIT M001183000 18-300 11319972 RENEGADE HI FLO 115/10 KIT M001183010 18-301 12703082 RENEGADE HI FLO 115/20 KIT M001183020 18-302 11279134 RENEGADE HI FLO 135/10 KIT M001183030 18-303 11296276 RENEGADE HI FLO 135/20 KIT

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KRA·August 26, 2009

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·August 26, 2011

    Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized using ethylene oxide, Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA Made in Ireland, Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182570 18257 Renegade" 18 150/10 (2-tip marker) M001182590 18259 Renegade" 18 150/20 (2-tip marker) M003182880US0 182880US Neuro Renegade" Hi Flo" 135/10 M003182890US0 182890US Neuro Renegade" Hi Flo" 135/20 M003182900US0 182900US Neuro Renegade" Hi Flo" 150/10 M003182910US0 182910US Neuro Renegade" Hi Flo" 150/20

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KRA·August 26, 2009

    Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006

    Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006

    Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 27, 2006

    20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

    FDA Enforcement
    Class II ·Terminated·Repro-Med Systems, Inc.·October 16, 2019

    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·December 22, 2021

    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·December 22, 2021

    Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·March 24, 2011

    Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 10, 2021

    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.

    FDA Enforcement
    Class II ·Terminated·Breg Inc, An Orthofix Company·September 12, 2012

    Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 10, 2021

    Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·May 3, 2005

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·May 3, 2005

    Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM) Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and Detachable 8" Extension with Option Lock; with 2 Vented Spikes and Double "Hi-Flo" Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd.

    FDA Recall
    Terminated ·Wolf Medical Supply Inc.·Product code MEB·October 20, 2011

    Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RATE 2mL/Hr. Model # CT-0020-270 Item # RFC270020. Manufactured by Medpro International (Thailand) Ltd.

    FDA Recall
    Terminated ·Wolf Medical Supply Inc.·Product code MEB·October 20, 2011

    Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd.

    FDA Recall
    Terminated ·Wolf Medical Supply Inc.·Product code MEB·October 20, 2011