16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023599·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·June 5, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
CORFLO ULTRA NG 8FR
FDA Adverse Event
Malfunction
·CORPAK MEDSYSTEMS·Product code KNT·June 6, 2013
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·January 18, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2019
AXIUM PRIME BRPL 3D
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 8, 2022
AXIUM PRIME BRPL 3D
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 8, 2022
RIST RADIAL ACCESS CATHETER
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code QJP·June 8, 2022
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
AXIUM PRIME BRPL 3D
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·June 8, 2022
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018