15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFE SPINE CROSS CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
BIOFIND
FDA 510(k)
FDA Class 2
·Neurology
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
FR CLERMONT FERRAND
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012
MERCY HSP PITTSBURGH PA 1
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·May 7, 2009
HCSG/HENDRICK MED/ABLNE TX 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code KFM·December 13, 2012
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 1, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
UNK
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 11, 2010
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