8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD
FDA 510(k)
FDA Class 2
·General Hospital
Stryker CrossFlow Integrated Arthroscopy Pump
FDA 510(k)
FDA Class 2
·Orthopedic
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 24, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·November 4, 2010
GENESYS HTA PROCERVA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·December 31, 2012
L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 22, 2013
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