13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100868·MCNEILL GLOBAL FIXATION RING LARGE
LUMINOS LOTUS MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·March 5, 2025
SMALL LUMEN PERITONEAL CATHETER
FDA 510(k)
FDA Class 2
·Neurology
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 27, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 31, 2013
MAXPLUS
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC·Product code FPA·September 30, 2014