21 results · 24ms · Sources: EU EUDAMED, US FDA

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XODUS MEDICAL ANTI-FOG SOLUTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

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

ARCHITECT CA 19-9XR

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 17, 2013

AXSYM RUBELLA IGG ANTIBODY

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code LFX·June 19, 2008

ENDOPLEGE CORONARY SINUS CATHETER

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DWF·April 19, 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

CLEARGLIDE EVH SMALL

FDA Adverse Event
Malfunction ·SORIN GROUP USA·Product code GEI·October 16, 2009

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NPT·February 20, 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