15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clear Guide SCENERGY
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293869·
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·June 17, 2020
PN 31X8 FRANCE 100BX
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 30, 2019
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·May 16, 2018
SRT II MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
HOSPIRA INFUSION BLOOD SETS
FDA 510(k)
FDA Class 2
·General Hospital
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·May 27, 2020
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·March 10, 2020
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 15, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
EQUINOXE REVERSE 46MM HUMERAL LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 7, 2024
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
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021