8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOMOVE 5000 SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607481·SKYTRON 3600 3.25" DELUXE GEL
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
FDA 510(k)
FDA Class 2
·Cardiovascular
VERDICT-II PROPOXYPHENE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SARA 300
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA SP. Z.O.O.·Product code FSA·April 19, 2013
NOVOSYN VIOLET 2/0 (3) 6X45CM
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A..·Product code GAM·August 27, 2014
AU681-02E CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024