12 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SWISSMEDA DENTAL PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
4000 3 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750008339·4000B STPCK 3WAY Y SHP 2in OD
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122230·KWire .045x9" (1.1x225mm)
Labrom Probe
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215069223·
Natura
FDA UDI
GENICON, INC.·00877972005834·
GeniLook
FDA UDI
GENICON, INC.·00877972002680·
DASH KNEE
FDA 510(k)
FDA Class 2
·Neurology
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
FDA 510(k)
FDA Class 2
·Orthopedic
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 14, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 23, 2014
*
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·May 27, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021