7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APLIO MX SSA-780A, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO VAXCEL DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 3, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
EQUATE DOUBLE ACTION DENTURE CLEANSER TABLETS
FDA Adverse Event
Other
·TOWER LABORATORIES, LTD.·Product code EFT·May 11, 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