12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNESIS PEEK CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
FDA 510(k)
FDA Class 2
·Immunology
SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
FDA 510(k)
FDA Class 2
·Physical Medicine
VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015
QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OXYGENRATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 3, 2013
SOFTHEAT
FDA Adverse Event
Other
·KAZ, INC.·Product code IRT·May 27, 2011
6 SHOOTER SAEED MUTLI-BAND LIGATOR
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code MND·August 14, 2008
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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