15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GyroStim
FDA 510(k)
FDA Unclassified
·Unknown
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777631·LUMBAMED BASIC DORSAL STAYS M SILVER I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I
CultureSwab™ MaxV
FDA UDI
COPAN ITALIA SPA·38053326002022·LQ Amies Single Plastic Applicators
DIASOL-ADDITIVES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUATRODE
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 18, 2013
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·May 19, 2026
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 10, 2020
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 18, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 18, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 16, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
FDA Enforcement
Class II
·Ongoing·Emergency Products & Research·April 3, 2024