7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
FDA 510(k)
FDA Class 2
·Hematology
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
FDA 510(k)
FDA Class 2
·Neurology
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 28, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015