7 results
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19ms
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Sources: EU EUDAMED, US FDA
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PILLING DISPOSABLE AORTA PUNCH
FDA 510(k)IMED 980 VOLUMETRIC INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 2, 2014
LIVIAN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 19, 2010
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012
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