10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTECURE; OPTECURE + CCC
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
FDA 510(k)
FDA Class 2
·Radiology
PLLA CANNULATED INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Citrine QTRAP Mass Spectrometer, Part Number 5063685
FDA Recall
Open, Classified
·AB Sciex, LLC·Product code DOP·August 30, 2023
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
PICC KIT: 4 FR X 19-5/8 (50 CM)
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code LJS·June 20, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 20, 2011
Citrine QTRAP Mass Spectrometer, Part Number 5063685
FDA Enforcement
Class II
·Ongoing·AB Sciex, LLC·October 11, 2023
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