8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
FDA 510(k)
FDA Class 2
·Hematology
GENZYME CONTRAST II HCG URINE/SERUM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FMI·April 29, 2022
SWANSON PILOT POINT BUR
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFF·April 9, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·February 25, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 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