15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
FDA 510(k)
FDA Class 2
·Orthopedic
FareTec PST
FDA UDI
FARETEC, INC.·B54122210230·FareTec PST, Tactical, Black, no case.
LEONE SPA
FDA UDI
LEONE SPA·08033707066200·PREFORMED LIGATURE WIRE 009"
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707191962·TruFit 2.0 022 MC UR6/7 NC SBT -14T 10Off DB SB...
Tizian Blank 5.0 translucent
FDA UDI
Pritidenta GmbH·04251366906000·
EN SNARE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code MMX·September 8, 2011
HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
FDA 510(k)
FDA Class 2
·Hematology
SPECTRUM V.0
FDA 510(k)
FDA Class 2
·Radiology
LUMOS VR-T
FDA Adverse Event
Death
·BIOTRONIK GMBH AND CO·Product code LWS·November 3, 2008
STERLING¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·August 23, 2011
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 23, 2015
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020