11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·April 26, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·June 3, 2011
VERSAFITCUP DM CEMENTLESS SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 17, 2015
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
AMISTEM H, HA COATED STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 17, 2017
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