10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile disposable examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
Bernafon
FDA UDI
Bernafon AG·05711584115435·CO3 MNR, 2.4G NFM MSIL CAPTO 3 GPL
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
FDA 510(k)
FDA Class 2
·Radiology
REPROCESSED ENDOSCOPIC TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFANT CPAP NASAL PRONG
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BZO·October 24, 2008
OCTRODE 60-CM PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011
M-1 COT - BASE HIGH LOAD 28
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 9, 2013
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023