15 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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CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707014270·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 9
ARx SAI
FDA UDI
Life Spine, Inc.·00190837196196·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837194727·
Arx
FDA UDI
Life Spine, Inc.·00190837175719·
TRIMED CLAVICLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
M-BOLUS EMBOLIC MICROSPHERES
FDA 510(k)
FDA Class 2
·Neurology
HUDSON CONCHA NEPTUNE
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BTT·October 6, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
HUDSON NEBULIZER, ADAPTORS 033
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·June 21, 2011
SVO2 CCO OPTIQ CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DQE·May 20, 2013
VITROS Chemistry Products COCM Reagent
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·January 29, 2014
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014