15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
primaLOK SP Interspinous Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
MILAGRO
FDA UDI
Medos International Sàrl·10886705010752·MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLG...
HIGH ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
FDA 510(k)
FDA Class 2
·Dental
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
FDA 510(k)
FDA Class 2
·Orthopedic
KEOFEED TUBE
FDA Adverse Event
Injury
·CORPAK·Product code FPD·October 31, 2014
COMPOSITCP 30 INTERFERENCE SCREW 7X25MM DUOSORB
FDA Adverse Event
Malfunction
·BIOMET SPORTS MEDICINE·Product code HWC·September 1, 2011
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·July 15, 2013
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
MILAGRO INSCR SMALL SIZE 6X23
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 17, 2019
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022