11 results
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19ms
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Sources: EU EUDAMED, US FDA
OVULON MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ITE HEARING AID, SAAPHIRE MODEL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
FDA 510(k)
FDA Class 2
·Radiology
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2013
12 FOOT EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 31, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 1, 2014
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
FDA Recall
Terminated
·Maquet Cardiopulmonary Ag Kehler Strasse 31 Rastatt Germany·Product code DWF·May 14, 2018
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
FDA Recall
Terminated
·Maquet Cardiopulmonary Ag Kehler Strasse 31 Rastatt Germany·Product code DWF·May 14, 2018
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
FDA Recall
Terminated
·Maquet Cardiopulmonary Ag Kehler Strasse 31 Rastatt Germany·Product code DWF·May 14, 2018
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·February 7, 2018
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code CBK·July 21, 2022