249 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Enforcement
Class II
·Completed·Illumina, Inc.·April 6, 2022
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
FDA Enforcement
Class II
·Completed·Caire, Inc.·November 27, 2024
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Recall
Completed
·Conformis, Inc.·Product code JWH·February 22, 2022
Medtronic SynchroMed, Model A10
FDA Recall
Completed
·Medtronic Inc.·Product code LKK·July 13, 2020
Destino Twist 14F (also branded as Guidestar 14F)
FDA Recall
Completed
·Oscor Inc.·Product code DYB·December 22, 2021
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·April 5, 2023
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Recall
Completed
·Hologic, Inc·Product code FZX·October 10, 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 Recall
Completed
·IMMUNDIAGNOSTIK, Inc·Product code DEG·March 27, 2023
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 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 Recall
Completed
·Iotamotion Inc·Product code QQH·September 12, 2024
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
FDA Recall
Completed
·Innomed, Inc.·Product code HWB·March 7, 2024
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·February 22, 2022
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
AggreGuide A-100 Instrument
FDA Recall
Completed
·Aggredyne, Inc.·Product code JOZ·July 23, 2019
LYFO Disk
FDA Recall
Completed
·Microbiologics Inc·Product code JTR·July 17, 2015
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
FDA Recall
Completed
·Exactech, Inc.·Product code LZO·June 29, 2021
illumina Model NextSeq 550 Dx REF 20005715
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·May 3, 2022