10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenZ HT+ 95x30 A4
FDA UDI
ARGEN CORPORATION, THE·D818122813·Dental porcelain/ceramic restoration kit
Zavation
FDA UDI
Zavation LLC·00842166188778·13mm Dilator
CARTRIDGE, 3ML RG MEDICATION
FDA Adverse Event
Malfunction
·CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD·Product code MRZ·March 17, 2022
EZONO 3000
FDA 510(k)
FDA Class 2
·Radiology
STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
FUSION NAVIGATION SYSTEM
FDA Adverse Event
MEDTRONIC NAVIGATION, INC.·Product code HAW·May 21, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 3, 2011
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025