10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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minisono
FDA 510(k)
FDA Class 2
·Radiology
MAHE FIXATION PLATE AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFINITI VISION SYSTEM WITH OZIL IP
FDA 510(k)
FDA Class 2
·Ophthalmic
HOODED ENHANCED ACETABULAR INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 7, 2019
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 8, 2011
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·October 17, 2014
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code PID·June 17, 2021
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PID·October 6, 2020
MANTIS REDUX BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·November 27, 2019