11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL RADIOGRAPHY, MODEL CXDI-55C
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450860052·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021613·
MOBILE-PATIENT VIEWER
FDA 510(k)
FDA Class 2
·Cardiovascular
AGILENT M2636A TELEMON MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
R SERIES PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012