8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPERTILT PLUS (STP)
FDA 510(k)
FDA Class 1
·Physical Medicine
ISPG, INC.
FDA registration
ISPG, INC.·4 products·🇺🇸 United States
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
FDA 510(k)
FDA Class 2
·Cardiovascular
SILKN BLUE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 3, 2014
PRIME ZOOM STRETCHER, 30" LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·August 16, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 2, 2013
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024