9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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cobas MRSA/SA Test
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I
LIVEWIRE ELECTOPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KOLIBRI SPINE
FDA 510(k)
FDA Class 2
·Neurology
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·October 2, 2014
LSLF EXT SET W CLV
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·May 24, 2013
ARTICUL/EZE BALL 32 +5 BR
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL·Product code JDI·June 15, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026