88 results
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11ms
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Sources: EU EUDAMED, US FDA
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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 5, 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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 5, 2018
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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 5, 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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 13, 2022
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 Enforcement
Class III
·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013
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 Enforcement
Class III
·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013
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 Enforcement
Class III
·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013
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 Enforcement
Class III
·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013
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 Enforcement
Class III
·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013
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 Enforcement
Class II
·Terminated·EMG Technology Co., Ltd.·September 24, 2014
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
FDA Enforcement
Class II
·Terminated·Skytron, Div. The KMW Group, Inc·June 8, 2016
EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table
FDA Enforcement
Class II
·Terminated·Skytron, Div. The KMW Group, Inc·June 8, 2016
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
FDA Enforcement
Class II
·Terminated·Skytron, Div. The KMW Group, Inc·January 20, 2016
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry
FDA Enforcement
Class II
·Terminated·Skytron, Div. The KMW Group, Inc·June 19, 2019
SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.
FDA Enforcement
Class II
·Terminated·Skytron, Div. The KMW Group, Inc·October 21, 2020
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
FDA Enforcement
Class II
·Terminated·Skytron, Div. The KMW Group, Inc·October 14, 2020