10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MICRO 2 SYSTEM
FDA 510(k)
FDA Class 1
·Dental
N/A
FDA UDI
Smith & Nephew, Inc.·00885556600900·MTO DILATOR 8MM CANNULATED 2.5MM
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
FDA 510(k)
FDA Class 2
·Cardiovascular
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 1
·Dental
1000 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 27, 2014
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 8, 2013
COULTER LH 750 SLIDEMAKER ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LOQ·November 16, 2010