8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052016159·Conical Double Full Radius Resector 4,2
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
FDA 510(k)
FDA Class 2
·Immunology
E.S.O. (ELECTRO SENSOR OXI)
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JMG·June 3, 2013
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