11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.
FDA Enforcement
Class II
·Terminated·Medspira, Llc·September 6, 2017
TAG-IT CYSTIC FIBROSIS KIT
FDA 510(k)
FDA Class 2
·Immunology
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
MARATHON
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 24, 2021
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 7, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 10, 2013
HS HAND CONTROLLED CURVED SHEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·September 5, 2008
MCKESSON CONSULT U120 URINE ANALYZER
FDA Adverse Event
Malfunction
·ACON LABORATORIES, INC.·Product code KQO·October 30, 2019