12 results · 22ms · Sources: EU EUDAMED, 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