9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Standard Staple-Line Reinforcement (SSLR23)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL™ Sensi-Disc™ Netilmicin 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316030·BD BBL™ Sensi-Disc™ Netilmicin 30 µg
SIGNA Artist Evo
FDA 510(k)
FDA Class 2
·Radiology
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 13, 2008
BECTON DICKINSON
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·August 30, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 17, 2013
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