23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PIPELINE TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II
T-Crystal cartridges Light Pink
FDA UDI
PERFLEX LTD·07290110506223·5 identical cartridges sealed in a vacuum bag ;...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857530959·Screw Based Distractor Size 45°
MP3CF ELECTRIC WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
INTEGRA ELECTRODE TUNNELING NEEDLE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 16, 2026
EYEVAN7285
FDA UDI
EYEVAN INC.·04571445039031·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582667985594·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582667985761·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582669060657·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582669054540·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582667986935·
EYEVAN7285
FDA UDI
EYEVAN INC.·04571445035811·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582667980209·
EYEVAN7285
FDA UDI
EYEVAN INC.·04582667982777·
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FNL·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013