9 results
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25ms
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Sources: EU EUDAMED, US FDA
ULTRA WAVE 101
FDA 510(k)
FDA Class 1
·Physical Medicine
VuePoint
FDA UDI
Nuvasive, Inc.·00887517182791·VP Screw, 3.5.x36mm Fav Ang Part Thread
TC sensor, Fixation kit
FDA UDI
Radiometer Medical ApS·05700699058362·TinyTeddy Fixation kit, fixation rings for Tiny...
OSTEONICS ECSI HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
MICROETCHER
FDA 510(k)
FDA Class 2
·Dental
PLM LFS PRIM PMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 29, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
ECHELON*FLEX60 LONG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 23, 2010
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