13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A&D Medical Blood Pressure Monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 17, 2019
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
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·May 31, 2013
THINLINE II STEROX
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 15, 2014
FREESTYLE LIBRE 3
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LTD·Product code QBJ·April 17, 2026