19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M.R. ASSOC. W TYPE GRASPING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209108121·KIT, RUF - ADVANCED - BLK
ACUMED
FDA UDI
Acumed LLC·10806378045646·Acutrak 2® - 7.5 Long Drill
T2 SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·December 11, 2018
NEXUS I.V. FLUID TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
FDA 510(k)
FDA Class 2
·Radiology
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 8, 2014
ZIMMER MMC CUP
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
FDA Recall
Open, Classified
·NeuroLogica Corporation·Product code IZL·December 28, 2023
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021