11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RUBEOLA IGG ELISA TEST
FDA 510(k)
FDA Class 1
·Microbiology
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117405742·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408111·
Lucitone® FRS®
FDA UDI
Dentsply International Inc.·D0019048540·
JOHN BUNN: MEDIX COMPACT TRAVELLER
FDA 510(k)
FDA Class 2
·Anesthesiology
GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
FDA 510(k)
FDA Class 2
·Radiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 4, 2014
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·January 9, 2013
CE INFUSOR LV 1.5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 22, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 31, 2025
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023