251 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Elos Accurate® Hybrid Base
FDA 510(k)
FDA Class 2
·Dental
MAS PLIF
FDA UDI
Nuvasive, Inc.·00887517444394·MAS PLIF Fixation Rod, 25mm Pre-Bent
MITEK
FDA UDI
Medos International Sàrl·10886705029013·Sheath with 2 Rotating Stopcocks compatible wit...
Introcan Safety ® 2
FDA UDI
B. BRAUN MEDICAL INC.·04046955840472·INTROCAN SAFETY 2 WL PUR 22GX45MM-US
SnuggleFit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022685·Interface Cable, SnuggleFit, Chest, Grael
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247645·No-Profile Interbody, 43mm x 30mm x 20mm, 25 Deg
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 3, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 3, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 10, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROLUMEN PN-1000
FDA 510(k)
FDA Class 2
·Physical Medicine
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 4, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 8, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK USA, INC.·Product code KWP·October 30, 2019