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Sources: EU EUDAMED, US FDA
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SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
FDA Enforcement
Class II
·Terminated·Vitrolife Inc·April 22, 2015
SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
FDA Recall
Terminated
·Vitrolife Inc·Product code KTO·December 22, 2014
QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·July 30, 2011
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·April 4, 2013
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·April 4, 2013
STANLEY Healthcare Arial 54315 Network Manager
FDA Recall
Terminated
·Stanley Security Solutions Inc·Product code IQA·June 14, 2019
Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·August 1, 2011
TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.
FDA Recall
Terminated
·TomoTherapy Incorporated·Product code MUJ·January 26, 2011
MRIdian Linac Radiation Therapy System, Model 20000.
FDA Enforcement
Class II
·Terminated·Viewray, Inc.·May 8, 2019
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code LNH·October 15, 2012
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·November 20, 2019
Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan
FDA Recall
Terminated
·TomoTherapy Incorporated·Product code MUJ·December 1, 2009
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 17, 2013
STA UNICALIBRATOR (ref. 00675)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020
MRIdian Linac Radiation Therapy System, Model 20000.
FDA Recall
Terminated
·Viewray, Inc.·Product code IYE·March 18, 2019
STA SYSTEM CONROL N + P (ref. 00678)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020
A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
FDA Recall
Terminated
·Steris Corporation·Product code FQO·February 17, 2010
A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
FDA Enforcement
Class II
·Terminated·Steris Corporation·September 26, 2012
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Enforcement
Class II
·Terminated·Iba Dosimetry·June 14, 2017
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Recall
Terminated
·Iba Dosimetry·Product code IYE·April 26, 2017