12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Precision GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021920·FPS 22mm Cannulated Metatarsal Reamer
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021802·OPTYC MBT CUS HK 0T +8A 018 UL
ImmunoCAP Tryptase Conjugate 50
FDA UDI
Phadia AB·07333066012025·ImmunoCAP Tryptase Conjugate 50
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249264·PrimePadPlus-K2-3422
PEERSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
FDA 510(k)
FDA Class 2
·Cardiovascular
BD¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·January 29, 2019
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
LAMITRODE S8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022