11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Alcon Research, LLC
FDA registration
Alcon Research, LLC·5 products·🇺🇸 United States
NA
FDA UDI
STERILMED, INC.·10888551020046·SAW BLADE MICRO RECIPROCATING
CONMED
FDA UDI
Conmed Corporation·10845854002223·MICRO RECIPROCATOR SAW BLADE, 25 MM X 7 MM
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 11, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code LFR·May 30, 2008
DA+ T SERIES DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·April 13, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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