252 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
FDA Recall
Completed
·C.R. Bard, Inc.·Product code EYZ·March 9, 2017
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
FDA Enforcement
Class II
·Completed·C.R. Bard, Inc.·April 26, 2017
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
FDA Enforcement
Class II
·Completed·Innomed, Inc.·May 8, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
FDA Enforcement
Class III
·Completed·Iotamotion Inc·November 13, 2024
Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
FDA Enforcement
Class II
·Completed·CHENICA INC.·February 20, 2013
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·July 7, 2021
LYFO Disk
FDA Enforcement
Class III
·Completed·Microbiologics Inc·March 23, 2022
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Enforcement
Class II
·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023
Medtronic SynchroMed, Model A10
FDA Enforcement
Class II
·Completed·Medtronic Inc.·December 20, 2023
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Enforcement
Class II
·Completed·Conformis, Inc.·April 20, 2022
Destino Twist 14F (also branded as Guidestar 14F)
FDA Enforcement
Class II
·Completed·Oscor Inc.·February 23, 2022
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
FDA Enforcement
Class II
·Completed·Medtronic Inc.·January 10, 2024
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·August 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
FDA Enforcement
Class II
·Completed·Exactech, Inc.·August 18, 2021
AggreGuide A-100 Instrument
FDA Enforcement
Class II
·Completed·Aggredyne, Inc.·September 7, 2022
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Enforcement
Class II
·Completed·Hologic, Inc·December 18, 2024
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Enforcement
Class II
·Completed·Illumina, Inc.·June 28, 2023