8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAROTID COIL 5000004901
FDA 510(k)
FDA Class 2
·Radiology
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PRESSURE WIRE SENSOR, MODEL 12003/12303
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON LEGACY MINI SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 3, 2013
OPTIQ CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·September 4, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 5, 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