13 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xonrid Gel
FDA 510(k)
FDA Unclassified
·Unknown
LEONE SPA
FDA UDI
LEONE SPA·08033707014515·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 33
Bone Curette
FDA UDI
ELLIQUENCE, LLC·00846338005641·
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575045730·Medullary canal orthopaedic reamer, rigid - End...
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575045747·Medullary canal orthopaedic reamer, rigid - End...
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575305612·Medullary canal orthopaedic reamer, rigid - End...
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001889·
ROTATING GAMMA SYSTEM INFINI (INFINI)
FDA 510(k)
FDA Class 2
·Radiology
KIMBA SPINAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
LAUREATE WORLD PHACO SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 6, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023