17 results · 23ms · Sources: EU EUDAMED, US FDA

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GrandioSO Unlimited

FDA 510(k)
FDA Class 2 ·Dental

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011251239200·ceraMotion® Ti Chroma Concept Dentin 9, 20 g / ...

NMI DUAL PORT II

FDA 510(k)
FDA Class 2 ·General Hospital

NuEra Tight Family, EMS Model

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 3, 2022

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·September 6, 2023

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 12, 2005

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 11, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Death ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 14, 2014

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 29, 2013

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·August 11, 2023

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·October 24, 2022

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 4, 2022

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 7, 2022

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 7, 2012

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·July 13, 2022

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025