7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITALOCK SOLID BACKED ACETABULAR SHELL
FDA 510(k)
FDA Class 2
·Orthopedic
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
FDA 510(k)
FDA Class 2
·Orthopedic
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
FDA 510(k)
FDA Class 2
·General Hospital
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·February 9, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 7, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024