11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ViSi Mobile Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Mouse anti-Pax5 (ZP007) Concentrate
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302008068·
POOLE SUCTION
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804270·POOLE SUCTION WITH VALVE
All Poly Monotrial UC
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215081294·
SEDAT MYSHELL LITE
FDA 510(k)
FDA Class 2
·Cardiovascular
SI-FIX SACROILIAC JOINT FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
BRAUN
FDA Adverse Event
Injury
·B.BRAUN MEDICAL INC.·Product code KPE·September 29, 2008
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024