9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PTCA STEERABLE HYDROPHILIC GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
EXPEDIO 500D R&F X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
FDA 510(k)
FDA Unclassified
·Unknown
WHITE X-TRA SLIDES CASE, 1440, MADE IN USA
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS·Product code KES·July 22, 2024
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 8, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 24, 2011
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
3.5MM LCP PERIARTICULAR PROX HUMERUS PL 10 HOLE/235MM/RT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·December 14, 2017
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
FDA Enforcement
Class II
·Ongoing·Biocare Medical, LLC·November 13, 2024