277 results
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Sources: EU EUDAMED, US FDA
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Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
FDA Enforcement
Class II
·Completed·Fukuda Denshi Co., Ltd.·December 13, 2017
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
FDA Recall
Completed
·Acumed LLC·Product code HWC·March 9, 2022
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
FDA Recall
Completed
·Acumed LLC·Product code HWC·March 9, 2022
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Recall
Completed
·STRATASYS LTD·Product code EBI·January 19, 2024
Pediatric Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Suction Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Upper Extremity Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Podiatry Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
FDA Recall
Completed
·GE Healthcare, LLC·Product code LNH·August 26, 2021
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Recall
Completed
·SynCardia Systems LLC·Product code LOZ·August 1, 2023
Vasc Custom Kit - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Neurosurgery Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015