3,057 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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osmed Hemi Socket Expander
FDA UDI
Osmed GmbH·EOSMEXH10201·osmed self-inflating tissue expanders are made ...
osmed Hemi Socket Expander
FDA UDI
Osmed GmbH·EOSMEXH0814P1·osmed self-inflating tissue expanders are made ...
osmed Hemi Socket Expander
FDA UDI
Osmed GmbH·EOSMEXH06111·osmed self-inflating tissue expanders are made ...
osmed Hemi Socket Expander
FDA UDI
Osmed GmbH·EOSMEXH09181·osmed self-inflating tissue expanders are made ...
osmed Hemi Socket Expander
FDA UDI
Osmed GmbH·EOSMEXH08141·osmed self-inflating tissue expanders are made ...
TRILOGY100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·April 20, 2026
TRILOGY100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·April 22, 2026
TRILOGY100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·April 23, 2026
TRILOGY100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·April 22, 2026
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code CBK·December 23, 2019
PURITAN BENNETT
FDA Adverse Event
Injury
·PURITAN-BENNETT CORP.·Product code CBK·October 25, 1994
AVEA VENTILATOR
FDA Adverse Event
Injury
·VYAIRE MEDICAL INC.·Product code CBK·June 30, 2022
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corp·April 18, 2018
EXH VLV ASSY, PED, MILL, ENGLISH
FDA Adverse Event
Other
·SECHRIST INDUSTRIES, INC.·Product code CBP·March 13, 2008
AVEA VENTILATOR
FDA Adverse Event
Injury
·VYAIRE MEDICAL·Product code CBK·October 21, 2019
VELA VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL·Product code CBK·April 28, 2023
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·July 25, 2023
VELA
FDA Adverse Event
Injury
·VIA SYS HEALTHCARE·Product code CBK·August 19, 2003
TRILOGY DR+
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·February 6, 1998
AVEA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·January 30, 2016