8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEST, (IVDP) ANTINUCLEAR ANTIBODY
FDA 510(k)
FDA Class 2
·Immunology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197447386·Love Gruenwald SWIVEL Rongeur
15.0 c...
ACUMED LASER, MODEL 1000
FDA 510(k)
FDA Class 2
·Physical Medicine
ABL90 FLEX PLUS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 18, 2014
PROSTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code KNS·September 26, 2012
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·July 12, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025