40 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TCM40 MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
LEONE SPA
FDA UDI
LEONE SPA·08033707066095·ELASTIC COTTON THREAD STRONG
Distal Hook Plate, Short, 3-Hole
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665024753·
Catalyst CSR Shoulder System
FDA UDI
CATALYST ORTHOSCIENCE INC.·00851388006227·Glenoid Trial, Right, Large
MONTANE TAURUS B-S2.F4 [SZER 120 CM] US
FDA UDI
MEDEN INMED SP Z O O·05903684802470·The MONTANE treatment table is a treatment tabl...
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
IMAGECHECKER-CT WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014
ARROW CVC SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·April 9, 2021
TRANSDUCER, S8 3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014
TRANSDUCER S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014
ARROW CVC SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·November 11, 2022
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·March 21, 2022
ARROW CVC SET: 16 GA X 8" (20 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 21, 2022
35 CM BIPOLAR LEAD
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL·Product code DTB·March 7, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 25, 2011
VITALITY 2 DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008