9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IQ BODY FLUIDS CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Mtira
FDA UDI
Kalitec Direct LLC·B07307K015706·Trial Drill Guide Tube, 6mm
WMT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXICAST PRIME
FDA 510(k)
FDA Class 2
·Dental
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 10, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 19, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011
Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
FDA Recall
Terminated
·Spacelabs Medical Incorporated·Product code CCK·July 20, 2005
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