8 results
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26ms
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Sources: EU EUDAMED, US FDA
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123045·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 100mm
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
FDA 510(k)
FDA Class 2
·General Hospital
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 17, 2013
COOK AIRWAY EXCHANGE CATHETER WITH RAPI-FIT ADAPTER
FDA Adverse Event
Death
·COOK MEDICAL INC.·Product code LRC·December 7, 2010
REDUCTION SPOON T2 FEMUR Ø9 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code LXH·July 9, 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