13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANCHORMAN Tibial Ligament Fixation Device
FDA 510(k)
FDA Class 2
·Orthopedic
PROFILE MULTI-PLATFORM SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRANSCEND 365 MINICPAP SYSTEM
FDA Adverse Event
Injury
·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
MEDTRONIC MINIMED·Product code OYC·September 27, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 21, 2011
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022