9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
FDA 510(k)
FDA Class 2
·Radiology
VULCAN TAC PROBES, MODEL 911XXX
FDA 510(k)
FDA Class 2
·Orthopedic
FUJI VII CAPSULE
FDA 510(k)
FDA Class 2
·Dental
CORAIL2 STD SIZE 13
FDA Adverse Event
Injury
·DEPUY FRANCE SAS-3003895575·Product code KWA·July 14, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 27, 2013
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 19, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015