9 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
FDA 510(k)
FDA Class 2
·Immunology
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C1MA021010·The Millennia Software system is indicated for:...
VENODYNE DVT ADVANTAGE MODEL 610
FDA 510(k)
FDA Class 2
·Cardiovascular
STEREOTAXIS CATHETER ADVANCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HEAD/NECK 24 STRETCH OBS 9/99
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 16, 2013
HEMOCRON
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·April 11, 2011
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 13, 2008
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