14 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATLANTIS Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Alpha Cup Inserter
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076351·
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001940·
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200160·Paxeon Head, Ceramic Size 32mm L
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111526230·Ceramic Femoral Head, 32mm, L (+4.0 mm)
BLUE POWDERFREE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SIGNATURE Head - BIOLOX Delta
FDA UDI
AMPLITUDE SAS·03701089520775·
PENUMBRA SYSTEM MAX ASPIRATION TUBING
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2015
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 5, 2013
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code MTA·June 22, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020