10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT RESTRAINT
FDA 510(k)
FDA Class 1
·General Hospital
Roadrunner Extra Support Wire Guide
FDA 510(k)
FDA Class 2
·Cardiovascular
AEQUALIS REVERSED ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 21, 2013
HOMEPUMP C-SERIES
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·January 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·January 19, 2021
REMINGTON MEDICAL DISPOSABLE PACING CABLE
FDA Adverse Event
Malfunction
·REMINGTON MEDICAL·Product code DSA·September 13, 2002
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026