12 results
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29ms
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Sources: EU EUDAMED, US FDA
QUANTUM LIGHT THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032816·Baltic Denture System BDLoad Sm6 PLSEbm6DFs A3,...
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
FDA 510(k)
FDA Unclassified
·Unknown
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011
ONE TOUCH ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 21, 2008
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 22, 2015
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024