11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMIGO ESCORT 7.5, MODEL 760001 PHS
FDA 510(k)
FDA Class 2
·Physical Medicine
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450363096·
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 19, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 3, 2013
MALYUGIN RING
FDA Adverse Event
Malfunction
·MICROSURGICAL TECHNOLOGY·Product code HNQ·September 10, 2014
FMP HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LPH·May 10, 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