11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114124·CHARLEUS CORTEX EXTR 23GA 16MM PK/10
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
FDA 510(k)
FDA Class 2
·Cardiovascular
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 10, 2008
PINNACLE MTL INS NEU36IDX54OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 18, 2013
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025
ALINITY I RUBELLA IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025