44 results
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22ms
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Sources: EU EUDAMED, US FDA
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
FDA Recall
Terminated
·Remel Inc·Product code JTN·August 21, 2012
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
FDA Recall
Terminated
·Animas Corporation·Product code LZG·December 17, 2012
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MHX·February 17, 2012
Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·January 13, 2012
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·September 17, 2012
Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·September 17, 2012
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code GEI·September 17, 2012
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code JJF·February 1, 2012
Zimmer Spine Ardis Inserter, Rx, non-sterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code MAX·November 12, 2012
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LEH·July 17, 2012
Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 17, 2012
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·July 13, 2012
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·July 13, 2012
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·July 13, 2012
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·July 13, 2012
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·July 13, 2012
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·July 13, 2012
Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.
FDA Recall
Terminated
·Vascular Solutions, Inc.·Product code DQY·January 17, 2012
LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.
FDA Recall
Terminated
·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code LLI·April 17, 2012
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code KAK·August 17, 2012