8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNIVERSAL HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code LFL·March 27, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
AUTOMATED IMPELLA CONTROLLER
FDA Adverse Event
Malfunction
·ABIOMED, INC.·Product code OZD·December 12, 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