8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPS EMPRESS
FDA 510(k)
FDA Class 2
·Dental
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613025359·Mayo-Harrington Scissors, Curved, Blunt Tips, O...
NUVANT, MOBILC CARDIAC TELEMETRY
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 14, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 11, 2010
ACCU-CHEK ® AVIVA EXPERT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·July 14, 2015
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