9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONASSE CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
LEONE SPA
FDA UDI
LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red
HCG RIA PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
SUCTION 3724217 HOUSE IRRIGATOR 2X2.5FR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code JZF·March 6, 2013
RP-LITE REMOTE PRESENCE SYSTEM
FDA Adverse Event
Death
·INTOUCH TECHNOLOGIES INC.·Product code DRG·February 8, 2011
REVEAL LINQ
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DSI·August 8, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020