9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLEXMEDICS GUIDEWIRE .012 ONLY
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756650328·SAL PACK
STERILE LATEX SURGICAL GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ELEVATORS, VARIOUS TYPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 4, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
ENDO GIA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·July 5, 2018
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024