8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4100 PATIENT OXIMETER MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
COLOSCREEN-ES
FDA 510(k)
FDA Class 2
·Hematology
LP(A)-LATEX SEIKEN ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
HAMMER 500 GRAMS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZY·April 9, 2013
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·February 25, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
HARMONY DELIVERY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPV·February 13, 2026
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