7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KOWA NONMYD ALPHA-DIII
FDA 510(k)
FDA Class 2
·Ophthalmic
V2 OTC Pain Relief TENS
FDA 510(k)
FDA Class 2
·Neurology
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 25, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 24, 2014
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code MND·January 6, 2011
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016