7 results
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34ms
·
Sources: EU EUDAMED, US FDA
ADEL - MODEL 986 INFANT WARMER
FDA 510(k)
FDA Class 2
·General Hospital
FUJIFILM Sonosite Vevo MD Imaging System
FDA 510(k)
FDA Class 2
·Radiology
SYNTEC ORTHODONTIC MINI SCREW
FDA 510(k)
FDA Class 2
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 24, 2014
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·October 27, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 30, 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