163 results
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45ms
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Sources: EU EUDAMED, US FDA
XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FSY·October 7, 2009
HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FSY·October 7, 2009
HANAULUX 2005 I cupola, P/N: 56076865. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FSY·October 7, 2009
ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·November 16, 2017
HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
FDA Recall
Terminated
·Steris Corporation·Product code FST·November 26, 2014
Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FSY·May 29, 2015
Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·February 23, 2009
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010
ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·February 23, 2009
Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005
Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005
Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/O2/IP/TP/BATT ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005
Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200 II 3LD/RSP/SP02 MDD MEDEXL. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005
Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005