10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General Hospital
AccuQuest
FDA UDI
Bernafon AG·05711584088494·AQ CO1 MNR, 2.4G NFM PB SABE/MSIL DEMO ACCUQ
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
CADSTREAM VERSION 5
FDA 510(k)
FDA Class 2
·Radiology
CUTERA QSWITCH LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC·Product code JXG·October 22, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 27, 2013
MERIT MANIFOLDS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 21, 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