176 results
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22ms
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Sources: EU EUDAMED, US FDA
OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.
FDA Recall
Terminated
·Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342·Product code LGW·April 22, 2008
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GKR·July 16, 2018
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·June 1, 2022
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 9, 2018
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 9, 2018
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 9, 2018
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
FDA Recall
Terminated
·EMG Technology Co., Ltd.·Product code JCX·August 3, 2014
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012
Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012
Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.
FDA Recall
Terminated
·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011
Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension set: 19'', 3.2 mL Vol., with injection site and male Luer Lock adapter, manifold extension set: 46'', 6.2 mL Vol, male luer adapter, and minivolume extension set: 10'', 0.7 mL Vol, injection site and stationary swivel lock T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FMG·December 15, 2005
Portex 3 Way Stopcock Catalog Number: T1103
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004
Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·June 11, 2008
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·April 20, 2015