8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLOSI RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLINDE OPTICS
FDA 510(k)
FDA Class 1
·Ophthalmic
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRKER CORP., MEDICAL DIV.·Product code FNL·December 29, 2010
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·January 17, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 3, 2014
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017