444 results
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38ms
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Sources: EU EUDAMED, US FDA
Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access
FDA Recall
Open, Classified
·ASTRA, LLC·Product code RFC·April 25, 2019
Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access
FDA Enforcement
Class II
·Ongoing·ASTRA, LLC·August 14, 2019
ASTRAL DC ADAPTER
FDA Adverse Event
Malfunction
·RESMED LTD·Product code CBK·June 30, 2017
ASTRAL DC ADAPTER
FDA Adverse Event
Malfunction
·RESMED LTD·Product code CBK·November 14, 2017
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·July 1, 2015
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·July 17, 2015
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·September 14, 2015
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·August 13, 2015
AMS MONARC SLING SYSTEM
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTN·September 14, 2015
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·September 18, 2015
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·July 17, 2015
AMS MINIARC PRO SINGLE INCISION SLING SYSTEM
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code PAH·December 19, 2014
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·July 16, 2015
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·July 1, 2015
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·August 5, 2015
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·September 17, 2015
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·September 29, 2015
AMS RETROARC RETROPUBIC SLING SYSTEM
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTN·September 29, 2015
AMS MONARC SLING SYSTEM
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTN·August 31, 2015
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·ASTORA WOMEN'S HEALTH LLC·Product code OTP·October 31, 2014