10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MILENIA PROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257073414·PROTECT PATELLA TRACKING BRACE, LT, MD
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788021595·Extension Set, 12"
EXTENSION SET, MODELS 1911-512
FDA 510(k)
FDA Class 2
·General Hospital
MMODIFICATION TO LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BRIGHTVIEW GAMMA CAMERA SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code KPS·May 27, 2014
CHIOCE GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·December 1, 2010
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025