22 results
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18ms
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Sources: EU EUDAMED, US FDA
FETAL HEART DETECTOR #'S D102 & D102R
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209108473·
WEHRS INCUS-STAPES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUCHECK ADVANTAGE
FDA Adverse Event
ROCHE DIAGNOSTICS CORP·Product code CFR·August 16, 2002
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·May 8, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
LEAVE ACTIVE PFC OVPAT38MM STD
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·August 10, 2010
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
FDA Recall
Open, Classified
·Roche Diabetes Care, Inc.·Product code LZG·July 28, 2021
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
FDA Recall
Open, Classified
·Roche Diabetes Care, Inc.·Product code LFR·July 28, 2021
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Recall
Open, Classified
·Roche Diabetes Care, Inc.·Product code NBW·July 28, 2021
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
FDA Recall
Open, Classified
·Roche Diabetes Care, Inc.·Product code LFR·July 28, 2021
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code NBW·April 14, 2014
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Recall
Terminated
·GSK Consumer Healthcare·Product code N/A·April 25, 2016
Accu-Chek Connect Diabetes Management App
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NDC·December 20, 2016
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 Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019
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 Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019
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 Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019
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 Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019
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 Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019