8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFIX CONFORMING PLUS TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
BECKMAN ANTI-STREPTOLYSIN O KIT
FDA 510(k)
FDA Class 1
·Microbiology
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
FDA 510(k)
FDA Class 2
·Radiology
POLYHESIVE PATIENT RETURN ELECTRODE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·February 6, 2013
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·December 28, 2010
MEGA 8FR 50CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·July 2, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015