11 results
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18ms
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Sources: EU EUDAMED, US FDA
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
FDA 510(k)
FDA Class 1
·Microbiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293968·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015239·Steinmann Pins, Single diamond, threaded, 1/8-i...
NA
FDA UDI
KEY SURGICAL, INC.·10849771050039·Steinmann Pins, Single diamond, threaded, 1/8-i...
ARTHROCARE SYSTEM 12000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BR-FHUS Viewer 1.0
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
ACCUSOL 35 5000ML (DRUG) (UK,IRELAND,POLAND,CZECH REP.,SLOV
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CASTLEBAR·Product code KPO·October 15, 2010
SCREWDRIVER TORX T7
FDA Adverse Event
Malfunction
·NEWDEAL SAS·Product code HXX·December 11, 2012
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
FDA Recall
Terminated
·Product code LZG·April 2, 2020
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
FDA Recall
Terminated
·Product code LZG·April 2, 2020