11 results
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26ms
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Sources: EU EUDAMED, US FDA
VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG
FDA 510(k)
FDA Class 2
·Ophthalmic
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198963·AK3 Congruent Insert Trial Size 2, 12mm
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331168178·obwegeser soft tissue retractor, 8 3/4" (22.2 c...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515329492·Boss K-Wire, 9" Dual Trocar, .054" Non-Sterile 6pk
WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
FDA 510(k)
FDA Class 2
·Physical Medicine
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·October 15, 2012
HORIZON APPLIER SMALL WIDE 8" CURVED
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·August 5, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018