16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
eSensor Warfarin Sensitivity Saliva Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Eagle Derma2 Nitrile Examination Gloves
FDA UDI
Eagle Protect Pbc·09421024254674·Derma2 Nitrile Examination Gloves, Black, Powde...
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524316·TRIAL 2152612 LARGE 12 DEGREES 12MM
Lightweight Drill Guide
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215114244·
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200122·Paxeon Head, Ceramic Size 28mm M
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001902·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111526120·Ceramic Femoral Head, 28mm, M (0.0 mm)
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
VOCO IONOFIL MOLAR AC QUICK
FDA 510(k)
FDA Class 2
·Dental
SIGNATURE Head - BIOLOX Delta
FDA UDI
AMPLITUDE SAS·03701089520737·
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2017
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
DEPUY
FDA Adverse Event
Product code JDI·January 24, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
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
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017