9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREELITE HUMAN LAMBDA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
ASPIRA PERITONEAL DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRASONIC SCALER ELEGANCE MS-10 (25K)
FDA 510(k)
FDA Class 2
·Dental
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 31, 2013
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 17, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017