9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENAX
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·October 21, 2019
VeriClear Digital Early Result Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLUCODR PLUS SYSTEM, MODEL AGM-3000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYPUMPC-BLOC SAF 2-14, 400ML, 2-14ML/HR+5ML/30
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·February 22, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 9, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
12MM/125 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HSB·March 1, 2021
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025