21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
FDA 510(k)
FDA Class 2
·Dental
CLEARGLIDE PRECISION BIPOLAR DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 2, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 14, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 14, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 14, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 16, 2009
CLEARGLIDE EVH LONGVIEW W/SCIS
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 23, 2009
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 16, 2009
CLEARGLIDE EVH SMALL W/SCISSOR
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·October 16, 2009
CLEARGLIDE EVH LONGVIEW W/SCIS
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 9, 2009
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013
PINN MAR +4 10D 28IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 22, 2008
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DRB·April 13, 2011
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 24, 2009
CLEARGLIDE EVH SMALL W/SCISSOR
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code GEI·November 3, 2009
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 13, 2021
CLEARGLIDE EVH SMALL
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code GEI·October 16, 2009
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