14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSRADIAL ARTERY ACCESS DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006502·2200D 2WAY YSHP .312OD/.250ID
devemed
FDA UDI
devemed GmbH·04061644033508·Mouth Gag "McKesson" L
for adults, black
plasti...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450851432·
Reicodent
FDA UDI
devemed GmbH·04061644054589·Mouth Gag "McKesson" L
for adults, black
plasti...
REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
FDA 510(k)
FDA Class 2
·General Hospital
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 14, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
GENDRON, INC·Product code FNL·September 24, 2014
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·June 3, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025