10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Precice® Screws
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITAL FOREHEAD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
VENTLAB 6000 SERIES HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 3, 2017
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 22, 2014
DERMAHOOK 1/2" HOOK
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDG·July 13, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013
Quanta System Sterile Optical Laser Fiber, reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
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