19 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZELTIQ SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127369·Apex Revision Knee System-Revision Femur Reamer...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690194903·Apex Revision Knee System-Revision Femur Reamer...
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
A & I WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 16, 2011
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL INC.·Product code HSX·May 15, 2014
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013
ELLIPSE DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 15, 2014
PRODISC-L INFERIOR ENDPLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MJO·May 6, 2011
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024