53 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Hoffmann LRF System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113707·CYSTOTOME FORMED 23GA
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
XISCAN 6000 IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Enforcement
Class II
·Terminated·Anodyne Surgical·June 23, 2021
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code KNT·October 16, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Recall
Terminated
·Anodyne Surgical·Product code HMX·April 21, 2021
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 7, 2025