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Sources: EU EUDAMED, US FDA
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FDA Recall
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HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea
FDA Recall
Terminated
·Marknew Products·Product code MQX·November 28, 2007
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
GE Healthcare Discovery IQ X-ray system
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·May 19, 2017
Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·December 22, 2009
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·June 2, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·June 2, 2016
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
FDA Recall
Open, Classified
·MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany·Product code NFJ·September 9, 2025
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
FDA Recall
Open, Classified
·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
FDA Recall
Open, Classified
·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
FDA Recall
Terminated
·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISY·January 4, 2016
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
FDA Recall
Terminated
·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISH·October 23, 2015