2,855 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306836237·Fistula Duct Probe,Probe & Needle Eye, Silver: ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable
Implant-One
FDA UDI
Implant Logistics, Inc.·D762APT0420150·Abutment, 400 Series Angled Post 2mm Cuff Heigh...
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369030·EXTENDED ADJUSTABLE BAR - SHORT
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
PREMIUM SURGICLIP II M-11.5 TITANIUM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code FZP·April 2, 2013
4 FR S/L POLY RADPICC WITH 70 CM PLATINUM TIP GUIDE
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·March 31, 2011
CONTAK RENEWAL 3 RF
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 4, 2017
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·December 24, 2014