41 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
FDA 510(k)
FDA Class 2
·Orthopedic
Field Shield Rx Wound Dressing,0.5oz spray
FDA UDI
Kericure Inc.·00858071004119·Topical burn and wound dressing, hydrogel barri...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310050·Probe, 1.5 inch Ball, Lenke, Curved, Black
Solidity Vertebral Body Replacement
FDA UDI
Ulrich Medical Usa, Inc.·00814386022446·End cap, oval, 19x16mm, 5°
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
Acapella One
FDA UDI
Choice Spine, LP·10885862244970·
MEDGEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·June 4, 2009
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 19, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 19, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 19, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 19, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 19, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 17, 2010
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·June 11, 2009
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 2, 2013