10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Airdog X8 Air Purifier (KJ800F-X8)
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO NXSTAGE SYSTEM ONE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STREAMLINE TL SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·July 12, 2018
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·December 11, 2018
55MM NTLC SELECTABLE RELOAD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 9, 2011
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·November 10, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 22, 2013
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·February 25, 2026