9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Interject Injection Therapy Needle Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
ILUMINAGE DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
CONTINUOUS NERVE BLOCK KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code CAZ·June 30, 2011
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·November 11, 2019
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021