11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SACS PRO
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10
BD AUTOSHIELD PEN NEEDLE
FDA Adverse Event
Injury
·BD MEDICAL - INFUSION THERAPY SYSTEMS·Product code FMI·October 27, 2011
KleenGel Dispenser
FDA 510(k)
FDA Class 1
·General Hospital
CLEAFIL DC CORE AUTOMIX
FDA 510(k)
FDA Class 2
·Dental
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·October 22, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 7, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 23, 2013
BD SYRINGE 10ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 3, 2025
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026