11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVEREST® Spinal System
FDA UDI
VB Spine LLC·10888857348011·Provisional Screwdriver (Long) Size 30
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
Klassic Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
PARALLEL SCREWDRIVER, SS
FDA Adverse Event
Injury
·ALPHATEC SPINE INC·Product code LXH·April 30, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 13, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 1, 2011
URETEX INTRODUCER NEEDLE X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·July 12, 2013
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024