12 results
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29ms
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Sources: EU EUDAMED, US FDA
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046370923·Rotary diamond instrument for dental application
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 1, 2020
ELTA WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2020
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - BELGIUM / S.A. - ALCON-COUVREUR N.V.·Product code KYG·May 15, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 26, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 14, 2011
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024