9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
FDA 510(k)
FDA Class 2
·Cardiovascular
LEVEL ONE CMF
FDA UDI
KLS-Martin L.P.·00888118094032·MESH, STANDARD, CONTOURED, 1.5 MM SCREW, CP TIT...
CD 3700 SL
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007
STC DIAGNOSTICS BENZOYLECGONINE EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)
FDA 510(k)
FDA Class 2
·Orthopedic
MAQUET HCU40 DEVICE
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DWC·April 3, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 11, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024