8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
FDA 510(k)
FDA Class 2
·Neurology
GUIDANT VISION
FDA Adverse Event
Malfunction
·GUIDANT CORPORATION·Product code MAF·July 13, 2005
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
FDA 510(k)
FDA Class 2
·Immunology
ENDOSCOPIC FIBEROPTIC CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 22, 2013
INTRALASE FS3 LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC.·Product code HNO·April 21, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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