9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXERCISE EVALUATION SYSTEM 2010
FDA 510(k)
FDA Class 2
·Anesthesiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756670845·GENERAL BASIN PACK
MOBILIMB CPM SHOULDER UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
SLT CONTACT LASER SYSTEMS (NEUROSURGERY)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLINITRON RITEHITE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·May 20, 2014
TENDRIL STS
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 5, 2012
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014