8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Penumbra LP Coil System
FDA 510(k)
FDA Class 2
·Neurology
AccuQuest
FDA UDI
Bernafon AG·05711584088500·AQ CO3 MNR T, 2.4G NFM DPB SABE/MSIL DEMO ACCUQ
REDSENSE-HOME USE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLYHESIVE RETURN ELECTRODE
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·October 22, 2014
VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KIH·June 27, 2013
MERIT MANIFOLDS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 21, 2011
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A
FDA Recall
Open, Classified
·ZOLL Circulation, Inc.·Product code DRM·March 4, 2025