12 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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RANGE SPINAL SYSTEM (MESA AND DENALI)
FDA 510(k)
FDA Class 2
·Orthopedic
CellaVision® Body Fluid Application DM1200
FDA UDI
Cellavision AB·07350040972557·The body fluid application automatically locate...
CellaVision® Advanced RBC Application DM1200
FDA UDI
Cellavision AB·07350040973745·When implemented together with CellaVision DM12...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197029681·Stevens vessel and tendon scissor
100mm,...
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORAL/ENTERAL SYRINGES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HRS·January 30, 2017
ENSEAL TRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GEI·May 14, 2013
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 25, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·June 7, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025