52 results
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23ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 8, 2022
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 8, 2022
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 8, 2022
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 8, 2022
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 8, 2022
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
FDA Enforcement
Class II
·Ongoing·Welch Allyn Inc·September 22, 2021
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·January 8, 2020
Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·January 8, 2020
Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·January 8, 2020
Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·January 8, 2020
Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·January 8, 2020
Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·January 8, 2020
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020