7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TERUFUSION THREE WAY STOPCOCK
FDA 510(k)
FDA Class 2
·General Hospital
SKELTEX ISV
FDA 510(k)
FDA Class 2
·Orthopedic
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014
CSF - SHUNT KIT, CONTOURED VALVE, REGULAR, LOW PRESSURE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·December 21, 2012
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 4, 2010
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024