22 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Athena GTX Device Management Suite (ADMS) Software
FDA 510(k)
FDA Class 2
·Cardiovascular
SONY LMD-2451MT LCD MONITOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARESCAPE V100
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH II
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 17, 2002
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·May 31, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 6, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 10, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 6, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·August 11, 2023
SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·October 14, 2020
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·June 16, 2022
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·September 27, 2024
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·March 29, 2023
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·December 1, 2022
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·December 1, 2022
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·December 7, 2022
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·December 7, 2022